GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases

Active Indication

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema+ [4]

Inactive Indication

Bronchiolitis Obliterans

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLC

Pearl Therapeutics, Inc.

AstraZeneca Investment (China) Co. Ltd.

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (18 Jun 2019),

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema

Regulation-

Structure/Sequence

Molecular FormulaC25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS Registry51333-22-3

View All Structures (3)

Clinical Trials associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

NCT06531798

/ Not yet recruitingPhase 4

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Start Date01 May 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT06844175

/ Not yet recruitingNot ApplicableIIT

A Prospective, Multicenter Cohort Study of Multidimensional Screening and Triple Drug Intervention in Young Patients with Chronic Obstructive Pulmonary Disease and Pre-chronic Obstructive Pulmonary Disease

At present, patients with early COPD and pre-COPD have not been paid attention to in clinical work. This study aims to actively screen such patients in high-risk groups to clarify their prevalence, monitor and analyze relevant clinical and biological indicators, and find sensitive indicators to assist in early diagnosis. Based on the updated definition of COPD in GOLD2022, we pay attention to the concept of early COPD and pre-COPD. After the completion of patient enrollment and data collection, we will further explore the effect of triple inhaled drug intervention on the development of lung function in patients with early COPD and pre-COPD, so as to provide clinical support for early screening and early treatment of COPD.
1. Patients with early COPD and pre-COPD were selected from 20 hospitals in 17 cities of Shandong province to understand the prevalence and basic characteristics of such diseases in the province, and then were divided into groups and treated.
2. The specificity and sensitivity of pulmonary function parameters (FEV1%,FEV1/FVC, DLco, etc.) and imaging parameters (MLD, Perc15, %LAA-950HU, etc.) alone or in combination in the diagnosis of early COPD and pre-COPD, and the predictive diagnostic model/system was established.
3. Treatment of early COPD and pre-COPD: eligible patients were given triple inhalation therapy or placebo, and the effects of triple inhalation therapy or not on clinical symptoms, pulmonary function, and imaging parameters were compared.
This study aims to determine the prevalence of early COPD in Shandong province and provide a reference for the treatment of this population.

Start Date01 Mar 2025

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

NCT06723756

/ RecruitingPhase 1

A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA in Healthy Adult Participants

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

Start Date23 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Translational Medicine associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Patents (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

Literatures (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

01 Apr 2025·AMERICAN JOURNAL OF MEDICINE

Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study

Article

Author: Müllerová, Hana ; Vogelmeier, Claus F. ; Hawkins, Nathaniel M ; Rhodes, Kirsty ; Vogelmeier, Claus F ; Marshall, Jonathan ; Pollack, Michael ; Anzueto, Antonio ; Hawkins, Nathaniel M. ; Rapsomaniki, Eleni

BACKGROUND:

Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiopulmonary and mortality risk, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce cardiopulmonary risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes with SITTs versus multiple inhaler triple therapies (MITTs).

METHODS:

SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's deidentified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.

RESULTS:

In the primary cohort, risk (hazard ratio [95% confidence intervals]) of all-cause mortality and a first severe cardiopulmonary event were 18% (0.82 [0.75, 0.91]) and 12% (0.88 [0.83, 0.93]) lower in patients initiating BGF versus MITT; results were consistent across censoring definitions, landmark periods, and sensitivity cohorts.

CONCLUSION:

In this real-world comparative effectiveness study of patients with COPD initiating BGF or MITT, BGF was associated with lower all-cause mortality and severe cardiopulmonary event risk versus MITT after accounting for between-group differences in baseline sociodemographic and clinical characteristics. This study supports the benefits of BGF over MITT and the need to consider proactive use of SITTs in COPD management.

01 Feb 2025·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS)

Article

Author: Arya, Niki ; Fredriksson, Martin ; Parikh, Himanshu ; Bowen, Karin ; Singh, Dave ; Movitz, Charlotta ; Mushunje, Alec ; Hurst, John R. ; Ojili, Nikki ; Patel, Mehul ; Martinez, Fernando J. ; Kisielewicz, Dobrawa ; Han, MeiLan K. ; Gale, Chris P.

Rationale: Chronic obstructive pulmonary disease (COPD) is associated with an increased risk of cardiovascular and cardiopulmonary events. In the phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality compared with dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF). However, the effect of BGF on cardiovascular events versus GFF remains unevaluated. Furthermore, the effect of BGF on time to first severe exacerbation has not been reported. Objectives: To assess the effects of BGF 320/18/9.6 μg (BGF 320) and other inhaled corticosteroid-containing arms on cardiovascular and severe cardiopulmonary endpoints versus GFF in patients with COPD from the ETHOS trial. Methods: Patients with moderate to very severe COPD and a history of exacerbations were randomized to twice-daily BGF 320, BGF 160/18/9.6 μg, BFF 320/9.6 μg, or GFF 18/9.6 μg (GFF). Time to first severe COPD exacerbation was a prespecified endpoint; post hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event, time to first cardiovascular adverse event (AE) of special interest, time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event. Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for time to first cardiovascular adverse event of special interest (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate to very severe COPD.

01 Dec 2024·ADVANCES IN THERAPY

Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Article

Author: Yoshida, Yuri ; Argoubi, Ramzi ; Müllerová, Hana ; Makita, Naoyuki ; Takahashi, Koichiro ; Issa, Seham ; Castañeda-Sanabria, Johann ; Nowacki, Grégoire ; Matsumoto, Isao

INTRODUCTION:

In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies.

METHODS:

This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users.

RESULTS:

A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common.

CONCLUSION:

Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease.

News (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

06 Feb 2025

·www.businesswire.com

AstraZeneca’s Full Year and Q4 2024 results

CAMBRIDGE, England--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CER i $m Actual CER - Product Sales 50,938 16 19 13,362 18 19 - Alliance Revenue 2,212 55 55 714 68 69 - Collaboration Revenue 923 56 54 815 >2x >2x Total Revenue 54,073 18 21 14,891 24 25 Reported EPS $4.54 18 29 $0.97 56 71 Core ii EPS $8.21 13 19 $2.09 44 49 Financial performance for FY 2024 (Growth numbers at constant exchange rates) Total Revenue up 21% to $54,073m, driven by a 19% increase in Product Sales, continued growth of partnered medicines (Alliance Revenue) and the achievement of sales-based milestones (Collaboration Revenue) Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%, V&I 8% and Rare Disease 16% Core EPS increased 19% to $8.21 Second interim dividend declared of $2.10 per share, making a total annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%. Dividend to be further increased in FY 2025 Guidance for FY 2025: Total Revenue is expected to increase by a high single-digit percentage and Core EPS is expected to increase by a low double-digit percentage, both at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Our company delivered a very strong performance in 2024 with Total Revenue and Core EPS up 21% and 19% respectively. We also delivered nine positive high value Phase III studies in the year, which coupled with increasing demand for our medicines in all key regions, will help sustain our growth momentum into 2025. This year marks the beginning of an unprecedented, catalyst-rich period for our company, an important step on our Ambition 2030 journey to deliver $80 billion Total Revenue by the end of the decade. In 2025 alone, we anticipate the first Phase III data for seven new medicines, along with several important new indication opportunities for our existing medicines. We are also investing in and making significant progress with transformative technologies that have the potential to drive our growth well beyond 2030, many of which have now entered pivotal trials.” Key milestones achieved since the prior results announcement Positive read-outs for Truqap in combination with abiraterone and androgen deprivation therapy in PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without chemotherapy in resectable early-stage EGFR m NSCLC (NeoADAURA) US approvals for Imfinzi in limited-stage small cell lung cancer (ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2- metastatic breast cancer (TROPION-Breast01) and Enhertu in chemotherapy-naïve HER2-low and -ultralow metastatic breast cancer (DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFR m NSCLC (LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally advanced or metastatic MET Exon 14 NSCLC (NCT04923945) Guidance The Company issues its Total Revenue and Core EPS guidance for FY 2025 at CER, based on the average foreign exchange rates through 2024. Total Revenue is expected to increase by a high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign exchange rates for February 2025 to December 2025 were to remain at the average rates seen in January 2025, it is anticipated that Total Revenue in FY 2025 would incur a low single-digit percentage adverse impact compared to the performance at CER, and Core EPS would incur a mid-single-digit percentage adverse impact. The Company’s foreign exchange rate sensitivity analysis is provided in Table 17. Capital allocation In FY 2025, the Company intends to increase the annual dividend declared to $3.20 per share. The Company also expects to increase capital expenditure iii by approximately 50%, driven by manufacturing expansion projects and investment in IT systems, to support portfolio growth and build capacity for transformative technologies. China In relation to the illegal drug importation allegations, in January 2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $0.9 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Imfinzi and Imjudo . A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable. AstraZeneca continues to fully cooperate with the Chinese authorities. In December 2024 AstraZeneca announced the appointment of Iskra Reic as Executive Vice President, International, which encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company while under investigation in China. Table 1: Key elements of Total Revenue performance in Q4 2024 % Change Revenue type $m Actual % CER % Product Sales 13,362 18 19 Alliance Revenue 714 68 69 $392m Enhertu (Q4 2023: $281m) $133m Tezspire (Q4 2023: $80m) $161m Beyfortus (Q4 2023: $41m) Collaboration Revenue 815 >2x >2x $600m Lynparza (Q4 2023: $245m) $111m Beyfortus (Q4 2023: $27m) $100m Koselugo (Q4 2023: nil) Total Revenue 14,891 24 25 Therapy areas $m Actual % CER % Oncology 6,344 27 29 Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at CER) CVRM 3,138 16 17 Farxiga up 21% (22% at CER) , Lokelma up 35% R&I 2,127 27 28 Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort up 31% (33% CER) V&I 651 58 55 Beyfortus Total Revenue up >3x Rare Disease 2,377 21 22 Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of 24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x Other Medicines 254 (7) (6) Total Revenue 14,891 24 25 Regions $m Actual % CER % US 6,532 28 28 Product Sales up 25% Emerging Markets 3,134 13 19 - China 1,364 (1) (3) Decline primarily due to low rates of seasonal respiratory viral infections, and impact from year-end hospital budget dynamics - Ex-China Emerging Markets 1,770 26 42 Europe 3,948 37 35 Product Sales up 20% (18% at CER) Established RoW 1,277 1 2 Total Revenue 14,891 24 25 Key alliance medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY 2023: $2,566m) Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $1,219m in FY 2024 (FY 2023: $653m) Table 2: Key elements of financial performance in Q4 2024 Metric Reported Reported change Core Core change Comments iv Total Revenue $14,891m 24% Actual 25% CER $14,891m 24% Actual 25% CER See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% Stable Actual +1pp CER 79% -1pp Actual Stable CER Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality, foreign exchange fluctuations and other effects R&D expense $4,677m 52% Actual 52% CER $3,573m 23% Actual 22% CER Increased investment in the pipeline Core R&D-to-Total Revenue ratio of 24% (Q4 2023: 24%) Reported R&D includes $753m impairment recorded against the vemircopan (ALXN2050) intangible asset SG&A expense $5,410m 1% Actual 1% CER $4,275m 6% Actual 7% CER Market development for recent launches and pre-launch activities Core SG&A-to-Total Revenue ratio of 29% (Q4 2023: 34%) Other operating income and expense v $100m -7% Actual -6% CER $101m -7% Actual -6% CER Operating Margin 14% +3pp Actual +4pp CER 28% +5pp Actual +6pp CER See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $365m 9% Actual 8% CER $310m 20% Actual 20% CER Recent debt issued at higher interest rates Decrease in interest income Higher level of Net debt Tax rate 10% +17pp Actual +15pp CER 16% +7pp Actual +7pp CER Variations in the tax rate can be expected between periods EPS $0.97 56% Actual 71% CER $2.09 44% Actual 49% CER Further details of differences between Reported and Core are shown in Table 12 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) Regulatory approval (EU, CN) Imfinzi Limited-stage SCLC (ADRIATIC) Regulatory approval (EU) Imfinzi Advanced endometrial cancer Regulatory approval (JP) Calquence Tablets for chronic lymphocytic leukaemia Regulatory approval (JP) Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory approval (US) Lynparza + Imfinzi Advanced endometrial cancer with mismatch repair proficiency (DUO-E) Regulatory approval (JP) Lynparza gBRCAm HER2- eBC (OlympiA) Regulatory approval (CN) Enhertu HR+ HER2-low and -ultralow mBC (DESTINY-Breast06) Regulatory approval (US) Datroway HR+ HER2- mBC (TROPION-Breast01) Regulatory approval (JP, US) Orpathys MET exon 14 skipping altered NSCLC (NCT04923945) Regulatory approval (CN) Fasenra EGPA (MANDARA) Regulatory approval (JP) Kavigale Prevention of COVID-19 (SUPERNOVA) Regulatory approval (EU, JP) Regulatory submissions or acceptances* Imfinzi Muscle-invasive bladder cancer (NIAGARA) Regulatory submission (US, JP) Imfinzi + Imjudo NSCLC (1st-line) (POSEIDON) Regulatory submission (CN) Calquence Chronic lymphocytic leukaemia (1st-line) (AMPLIFY) Regulatory submission (EU) Datroway EGFR m NSCLC (later line) (TROPION-Lung05) Regulatory submission (US) Tezspire Severe uncontrolled asthma (NAVIGATOR/ DIRECTION) Regulatory submission (CN) Koselugo Neurofibromatosis type 1 adult (KOMET) Regulatory submission (EU, JP) Phase III / registrational data readouts and other developments Tagrisso Resectable early-stage EGFR m NSCLC (NeoADAURA) Primary endpoint met Truqap PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Other pipeline updates In January 2025, the vemircopan (ALXN2050) Phase II development programme was terminated. The decision was based on safety and efficacy data from Phase II trials. Upcoming pipeline catalysts For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html . Sustainability highlights The Company convened an event on health equity for investors and analysts in November that detailed AstraZeneca’s health equity strategy, which is embedded from the Company’s science through to healthcare delivery and community engagement. At the end of 2024, the Company’s cumulative reduction in Scope 1 and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline. Conference call A conference call and webcast for investors and analysts will begin today, 6 February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its Q1 2025 results on 29 April 2025. To read AstraZeneca's Full Year and Q4 2024 Financial Results press release in full, click here .

Phase 2Financial StatementExecutive ChangeDrug ApprovalPhase 3

15 Jan 2025

·www.pharmaceutical-technology.com

JP Morgan 2025: AstraZeneca promises a ‘catalyst-rich’ year ahead

AstraZeneca CFO Aradhana Sarin promised Phase III readouts and revenue growth in 2025 despite ongoing investigations of its Chinese operations. Credit: Bloomberg/ Getty Images AstraZeneca says a strong 2024 and stacked pipeline spells potential for further growth in 2025 as the company aims to bring in $80bn in revenue by 2030. CFO Aradhana Sarin outlined AstraZeneca’s plans at the 2025 JP Morgan Healthcare Conference in San Francisco on 15 January. The company maintains a confident outlook for the new year, said Sarin, despite its share price decline in the latter half of 2024. During her presentation, Sarin focussed on the company’s performance during the first nine months of 2024, during which AstraZeneca increased total revenue by 19% against the same period in 2023 . Additionally, cash flow rose by almost $1bn over the prior year. The company’s growth was largely attributed to its expanded clinical pipeline, which includes late-stage trials that have increased in number from 77 in 2022 to 91 in 2024. This year promises to be a “catalyst-rich” year for AstraZeneca, according to Sarin, with 21 new molecular entities (NMEs) in late-stage development, seven of which are expected to yield Phase III readouts within the next year. Among these are gefurulimab, being trialled in myasthenia gravis (NCT05556096), and efzimfotase alfa, trialled in hypophosphatasia (NCT06079281), the progress of which Sarin attributed to accelerated recruitment rates. Sarin did, however, note negatively impacted revenues in China given ongoing investigations of AstraZeneca’s operations in the country by authorities. On 30 October 2024, AstraZeneca’s Chinese operations president Leon Wang stood down and was detained along with other current and former employees amidst accusations of insurance fraud, data breaches, and import of unlicenced medicines. Revenues for AstraZeneca in the US, in comparison, increased by 20% in the first nine months of 2024, comprising 43% of total revenue and are expected to account for half of the company’s revenues by 2030 according to Sarin. She identified respiratory and immunology as the company’s foremost sectors, growing by 39% in Q4 of 2024. Additionally, she said assets like Breztri (budesonide + formoterol fumarate + glycopyrrolate) and Fasenra (benralizumab) are positioned for indication expansion into severe asthma and chronic obstructive pulmonary disorder (COPD), respectively, during 2025. Sarin said AstraZeneca’s capital allocation priorities are unchanged for the coming year and that the company remains focussed on antibody-drug conjugates, bispecific antibodies, and cell therapies, in addition to continuing its foray into the metabolic and gene editing space. Like many other companies that rose to prominence during the Covid-19 pandemic, AstraZeneca has made concerted efforts to break into the obesity market, and has tried going through the deal rout with its potential acquisition agreement with SixPeaks Bio , announced in May 2024.

AcquisitionPhase 3

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

100 Deals associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchitis, Chronic	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Disease, Chronic Obstructive	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Emphysema	Japan	AstraZeneca KK	18 Jun 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	Pearl Therapeutics, Inc.	20 Aug 2015
Severe chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol (BGF)	ktxhgytrcb(znjvovwnuf) = vcrjlrmtrw jpfkrxkhky (zbhseberuu )	-	19 May 2024
				Multiple Inhaler Triple Therapy (MITT)	ktxhgytrcb(znjvovwnuf) = radifuplqv jpfkrxkhky (zbhseberuu )
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	rtsyplroct(mlxzvrkruq): HR = 0.61 (95% CI, 0.38 - 0.95), P-Value = 0.030	-	21 May 2023
				Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
ATS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Prompt BGF initiation (≤30 days)	aoitdkacwz(hnpvoszmwb) = qrzlpjxrvo xkwvjycqch (kvmqpizucl, 0.04 - 0.09) View more	-	21 May 2023
				Delayed BGF initiation (31-180 days)	aoitdkacwz(hnpvoszmwb) = ebqcgtsfwg xkwvjycqch (kvmqpizucl, 0.06 - 0.10) View more
NCT02497001 (Pubmed \| Appl Health Econ Health Policy)	Phase 3	Severe chronic obstructive pulmonary disease	1,902	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	wcdyfjgrnm(ouggmahmaw) = mweulfvogo hbxqxuszmr (kvlizpsqdc ) View more	-	01 Sep 2022
				Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA)	wcdyfjgrnm(ouggmahmaw) = huftjnimel hbxqxuszmr (kvlizpsqdc ) View more
NCT03836677 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Budesonide/glycopyrrolate/formoterol fumarate	jxfqfefamz(gxdmgmzdhh): GM = 1.09 (95% CI, 1.03 - 1.16)	-	01 Jul 2021
				Glycopyrrolate/formoterol fumarate
NCT02497001 (KRONOS, Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,896	Budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI)	xjonmzzhmq(desvuucozb) = gqbqwrqqet xcwxpjensq (bmwktwtxqn )	-	28 Jun 2021
				Budesonide/formoterol fumarate dihydrate (BFF) MDI	xjonmzzhmq(desvuucozb) = dyssbctiul xcwxpjensq (bmwktwtxqn )
ATS2021	Not Applicable	Severe chronic obstructive pulmonary disease	-	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/18/9.6 µg	mthfhyxsej(wydadpxpyu) = gnehqxgzzn klwrypuhgi (adgfjesdyv ) View more	-	03 May 2021
				Long-Acting Muscarinic Antagonist/Long-Acting β2-Agonist (LAMA/LABA)	mthfhyxsej(wydadpxpyu) = knkvlezwsr klwrypuhgi (adgfjesdyv ) View more
NCT02536508 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	627	Budesonide Gylcopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 ug)	qbsociovsz(xpprgauehc) = louumnlzrw qhztlhzbgo (xhirulxsun, qczkznitnj - khhqstqzih) View more	-	26 Feb 2021
				Glycopyrronium+Formoterol Fumarate (GFF MDI 14.4/9.6 ug)	qbsociovsz(xpprgauehc) = llkxqqzntn qhztlhzbgo (xhirulxsun, vmgzppaiiy - tubjgwfxbt) View more
NCT02465567 (ETHOS, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	8,588	Budesonide+Glycopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 μg)	kxdexjaxua(eqnxnehlxz) = ksgrhwjjwj eudzloyyul (inekmpuevm, 0.04) View more	-	02 Feb 2021
				BGF (BGF MDI 160/14.4/9.6 μg)	kxdexjaxua(eqnxnehlxz) = cinfumxcej eudzloyyul (inekmpuevm, 0.04) View more
NCT03075267 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	96	PT010 (BGF MDI) 320/14.4/9.6 µg (PT010 (BGF MDI) 320/14.4/9.6 µg)	whatpmowoy(oaklajfsee) = mmufyctcnu tecostllmj (dkfyxvwejc, 67.6) View more	-	19 Jan 2021
				PT010 (BGF MDI) 160/14.4/9.6 µg (PT010 (BGF MDI) 160/14.4/9.6 µg)	whatpmowoy(oaklajfsee) = ilqphhcsks tecostllmj (dkfyxvwejc, 98.1) View more

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