Request Demo

Last update 08 May 2025

Nirsevimab

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-RSV MAb-YTE, Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897 .gamma.1-chain), disulfide with monoclonal med18897 .kappa.-chain, dimer, Immunoglobulin g1-kappa, anti-(human respiratory syncytial virus fusion glycoprotein f0 (protein f))human monoclonal antibody.gamma.1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03

+ [13]

Target

RSV F protein

Action

inhibitors

Mechanism

Respiratory syncytial virus F protein inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Respiratory Syncytial Virus InfectionsPneumonia due to respiratory syncytial virusLower Respiratory Tract Infections

Inactive Indication-

Originator Organization

AstraZeneca AB

Active Organization

Sanofi Pasteur SA

AstraZeneca PLC

Sanofi Winthrop Industrie SA

+ [5]

Inactive Organization

MedImmune LLC

License Organization

Dr. Reddy's Laboratories Ltd.MedImmune Pharma BV

SK bioscience Co., Ltd.

+ [7]

Drug Highest PhaseApproved

First Approval Date

European Union (31 Oct 2022),

Pneumonia due to respiratory syncytial virus

RegulationPRIME (European Union), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom), Fast Track (United States), Breakthrough Therapy (United States), Priority Review (China)

Structure/Sequence

Sequence Code 64418264L

Source: *****

Sequence Code 315645337H

Source: *****

Clinical Trials associated with Nirsevimab

NCT06856967

/ RecruitingNot ApplicableIIT

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: a Case-Control Study

This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.

Start Date04 Dec 2024

Sponsor / Collaborator-

NCT06172660

/ RecruitingNot ApplicableIIT

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?

Start Date01 Oct 2024

Sponsor / Collaborator

Yale University

[+1]

NCT06551506

/ RecruitingPhase 4IIT

A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.

Start Date19 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Nirsevimab

100 Translational Medicine associated with Nirsevimab

100 Patents (Medical) associated with Nirsevimab

250

Literatures (Medical) associated with Nirsevimab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Respiratory syncytial virus immunization with nirsevimab: Acceptance and satisfaction assessment in infants and risk groups in the region of Murcia (Spain)

Article

Author: Jesús Pérez Martín, Jaime ; Zornoza-Moreno, Matilde ; de la Cruz Gómez Moreno, María ; del Pilar Ros Abellán, María ; Sánchez Manresa, Susana

Respiratory syncytial virus (RSV) is a leading cause of respiratory infections in infants under two years of age, often resulting in bronchiolitis and pneumonia, which contribute to high hospitalization rates. The recent approval of nirsevimab, a long-acting monoclonal antibody, has provided an immunization alternative for infants, addressing the substantial burden of RSV. This study aimed to evaluate acceptance and satisfaction among parents or legal guardians of infants who were candidates for immunization with nirsevimab in the Region of Murcia (Spain) during the 2023-2024 campaign. A cross-sectional survey, encompassing 1692 parents of immunized infants and 219 of non-immunized infants, revealed a high acceptance rate for nirsevimab, with 87% of parents indicating willingness to immunize a future child and 86.6% willing to recommend it. Concerns about safety and side effects were the primary reasons for hesitation among parents who did not immunize their infants. These findings underscore the importance of enhancing educational efforts in future campaigns to address safety concerns, thereby supporting broader RSV immunization coverage in the pediatric population.

31 Dec 2025·Journal of Medical Economics

Cost-effectiveness of wastewater and environmental monitoring of respiratory syncytial virus to guide universal infant immunoprophylaxis in Canada

Article

Author: Mercier, Élisabeth ; Paes, Bosco A. ; Rodgers-Gray, Barry S. ; Keary, Ian P. ; Thampi, Nisha ; Delatolla, Robert ; Fullarton, John R.

AIMSTo compare the cost-effectiveness of wastewater and environmental monitoring (WEM) versus clinical surveillance (CS)-guided respiratory syncytial virus (RSV) prophylaxis programs in Canada.MATERIALS AND METHODSA cost-utility model was developed comprising two identical decision trees for RSV-WEM and RSV-CS. Within each tree, children could conservatively receive nirsevimab prophylaxis (71% coverage) or not at the start of the RSV season and subsequently experience an RSV-related hospitalization, medically-attended, non-hospitalized RSV-infection, or be uninfected/non-medically attended. All children could experience respiratory morbidity up to age 18 years, with higher rates following RSV-related hospitalization. All prophylaxis and RSV-related costs were identical for RSV-WEM and RSV-CS. No costs were assumed for RSV-CS; whereas a cost of CAD$12.31 per infant (infrastructure: CAD$4.07 plus sampling: CAD$8.24) was assumed if a new RSV-WEM system was initiated, with all infrastructure costs included in year 1. Predicated on data from the 2022-23 Ontario RSV season, RSV-WEM was assumed to provide a 15.1% benefit for earlier initiation of the prophylaxis program versus RSV-CS. Outcomes were modelled over an 18-year time horizon (1.5% discounting).RESULTSRSV-WEM dominated (lower costs and higher utilities) RSV-CS and remained unaltered in all scenario analyses. Scenarios included: amortization of RSV-WEM infrastructure costs over 5 years; using existing WEM infrastructure for RSV detection; 25% reduction in extra cases identified by RSV-WEM; 50%-90% prophylaxis coverage based on real-world data; and 25% increase in the cost of RSV-WEM.CONCLUSIONSThe integration of RSV-WEM appears a highly cost-effective strategy (vs RSV-CS exclusively) to guide the earlier launch of RSV seasonal prophylaxis in Canada.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Health economic evaluation of implementing a universal immunization program with nirsevimab compared to standard of care for the prevention of respiratory syncytial virus disease in Canadian infants

Article

Author: Wu, Jianhong ; Greenberg, Michael ; Kieffer, Alexia ; Lee, Jason Kh ; Shin, Thomas

Respiratory syncytial virus (RSV) is a highly contagious pathogen and a leading cause of severe lower respiratory tract illness (LRTI) in infants and young children, irrespective of risk factors. Nirsevimab, an extended half-life monoclonal antibody, was approved in Canada in 2023 as a passive immunizing agent for the prevention of RSV LRTI. This study evaluated the optimal price per dose (PPD) at commonly accepted willingness-to-pay (WTP) thresholds among Canadian infants compared to the current standard of care (i.e. palivizumab for preterm infants and those with specific medical conditions). A static decision tree model was developed to assess the impact of nirsevimab on RSV-related health and economic outcomes among Canadian infants - including outpatient physician and emergency department visits, inpatient hospitalizations including intensive care unit (ICU) admissions and mechanical ventilation, and the associated healthcare costs of these outcomes. The model utilized Canadian epidemiological and cost inputs where possible, adopting a societal perspective. Compared to the standard of care, nirsevimab was expected to prevent 47,609 RSV-related health events, including 2,296 hospitalizations and a reduction of approximately $45 million in direct healthcare costs. At a WTP threshold of $50,000 per quality-adjusted life-year (QALY), the estimated base case PPD was $536, based on average cost assumptions across several costing scenarios. These findings suggest that universal immunization with nirsevimab could significantly reduce the health and economic burden of RSV among Canadian Infants.

256

News (Medical) associated with Nirsevimab

08 Apr 2025

·www.astrazeneca.com

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025

AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) in Vienna, Austria, from 11-15 April 2025. With 13 abstracts, including two oral presentations and two late-breaking poster presentations, the Company will highlight progress in advancing novel immunisations against bacterial and viral infectious diseases and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection. Benjamin Moutier, Senior Vice President, Vaccines & Immune Therapies, AstraZeneca said: “AstraZeneca is building an innovative portfolio of antibodies and vaccines to tackle two of the top global public health threats – serious bacterial infections and respiratory viral infections. At ESCMID, we’ll share data on three novel monoclonal antibodies targeting high-priority pathogens, highlighting our ambition to redefine care for serious bacterial infections. In addition, we will present 20 years of effectiveness data for Fluenz/FluMist, as well as real-world data highlighting the ongoing burden of RSV and hMPV, two leading causes of respiratory illnesses.” Advancing potential new options for serious bacterial infection prevention and treatment Serious bacterial infections pose significant and growing threats to global health, linked to an estimated 7.7 million deaths a year globally, leading to increasing morbidity and mortality for patients and a substantial burden on health systems.1 At ESCMID, the Company will share preclinical data on investigational monoclonal antibodies (mAbs) targeting three of the top five pathogens identified as urgent risks by the Centers for Disease Control and Prevention: Staphylococcus aureus (S. aureus): Oral presentation on in vivo expression of an mRNA-encoded multi-mechanistic mAb combination against S. aureus. There are millions of methicillin-resistant S. aureus (MRSA) infections annually worldwide, and MRSA is resistant to many types of antibiotics, making treatment highly complex. A pathogen-specific treatment strategy with mAbs targeting some S. aureus virulence factors represents an alternative to broad spectrum antibiotics.2 Pseudomonas aeruginosa (P. aeruginosa): Preclinical data showing that gremubamab, an anti-P. aeruginosa bispecific human mAb, may enhance neutrophil-mediated killing of P. aeruginosa in bronchiectasis patients. P. aeruginosa is a pathogen that colonizes one-third of patients with bronchiectasis, a chronic lung condition impacting about one million people globally and drives significant disease morbidity and mortality.3 Klebsiella pneumoniae (K. pneumoniae): Research on the development and characterisation of bispecific antibodies that protect against bacteraemia and pneumonia from the major serotypes of antibiotic-resistant K. pneumoniae in mouse models. Infections caused by K. pneumoniae are responsible for more than 700,000 yearly deaths worldwide.4 Real-world data examining the impact of respiratory infections AstraZeneca is presenting 20 years of real-world data on Fluenz/FluMist (live attenuated influenza vaccines, LAIV), recently approved in the U.S. as the only vaccine for self- or caregiver administration for the prevention of influenza, demonstrating long-term effectiveness comparable to that of inactivated (IIV) influenza vaccines in children.5 The Company will also present two late-breaking posters featuring real-world studies in patients with haematological malignancies who are highly susceptible to severe respiratory infections. The studies show that outcomes from human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) were similar to those from influenza and COVID-19, highlighting the need for development of novel options for preventing disease caused by hMPV and RSV.6,7 Retrospective analyses from Valencia, Spain, where there is systematic testing for multiple respiratory viruses, highlight the impact of RSV and influenza on severe disease and mortality in older adults throughout the COVID-19 pandemic, and suggest a potentially greater proportion of mechanical ventilation use and in-hospital death from RSV than influenza in adolescents and adults.8,9 Additional real-world data from France highlight the extensive healthcare resource utilisation due to hMPV and RSV and underline the need for routine testing for hMPV to accurately assess its true burden.10 Additionally, data being presented by our partner, Sanofi, confirm the significant public health impact and real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants.11 Furthering Research in COVID-19 Prevention Data on AZD6563, an investigational novel COVID-19 mRNA vaccine-like particle (VLP) vaccine, demonstrating that a low dose may elicit equivalent cell-mediated immunity to a licensed mRNA vaccine will also be shared.12 Additionally, data will be presented increasing confidence in a SARS-CoV-2 variant-agnostic threshold which could be used as a surrogate endpoint for benchmarking expected efficacy of novel mAbs for the prevention of COVID-19 against emerging variants.13 Key AstraZeneca presentations during ESCMID 2025 Abstract Title Presentation Details Abstract Title Early Science: Serious Bacterial Infections and Respiratory Viral Infections Abstract Title In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model Presentation Details Oral Presentation Session Title: Around the Lab in 80 Ways: A Journey Through Innovative Therapeutics Date: Saturday 12 April 2025 Time: 11 AM – 12 PM CEST Location: Hall 13 Abstract Title Low dose of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title A Bispecific Monoclonal Antibody Targeting Psl and PcrV Enhances Bronchiectasis Patient Neutrophil-Mediated Killing Of Pseudomonas aeruginosa Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-World Evidence: Respiratory Infections Abstract Title Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: A matched cohort analysis Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematological malignancies Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Similar proportions and temporal patterns of influenza, RSV, and hMPV among ESKD patients tested between 2020-2023 Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Characterization of hMPV and RSV cases in the French national hospital claims database during the 2022-2023 season Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Shifting viral landscapes: the impact of SARS-CoV-2 on hospitalization, ICU admission, and mortality in respiratory infections among older adults in Valencia, Spain Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Respiratory syncytial virus (RSV)-associated hospitalised influenza-like illness (ILI) and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015-2019/2020: the VALSARI study Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA) Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title COVID-19 mAbs Abstract Title Pharmacokinetics and immunogenicity of AZD7442 (Tixagevimab/Cilgavimab) in hospitalised COVID-19 patients: results from the DisCoVeRy trial Presentation Details Oral Presentation Session Title: New developments in prophylaxis and treatment of COVID-19 Date: Saturday 12 April 2025 Time: 11:00 Location: Hall 6 Abstract Title A threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Notes AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. GBD 2019 Antimicrobial Resistance Collaborators. Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2022 Dec 17;400(10369):2221-2248. 2. Tkaczyk C, Newton M et al. In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model. Oral Presentation. ESCMID Global 2025; Vienna, Austria. 2025. 3. Long MB, Gilmour A et al. A bispecific monoclonal antibody targeting Psl and PcrV enhances bronchiectasis patient neutrophil-mediated killing of Pseudomonas aeruginosa. Poster Presentation #P3642. ESCMID Global 2025; Vienna, Austria. 2025. 4. Doyle M, Smith A et al. Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen. Poster Presentation #P2377. ESCMID Global 2025; Vienna, Austria. 2025. 5. Stuurman AL, Enxing J et al. Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA). Poster Presentation #P0120. ESCMID Global 2025; Vienna, Austria. 2025. 6. Salmanton-Garcia J, Marchesi F et al. Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: a matched cohort analysis. Poster Presentation #P5067. ESCMID Global 2025; Vienna, Austria. 2025. 7. Marchesi F, Salmanton-Garcia J et al. Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematologic malignancies. Poster Presentation #P5066. ESCMID Global 2025; Vienna, Austria. 2025. 8. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0131. ESCMID Global 2025; Vienna, Austria. 2025. 9. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0132. ESCMID Global 2025; Vienna, Austria. 2025. 10. Binh Luong Nguyen L, et al. Characterisation of hMPV and RSV hospitalisations in the French national hospital claims database during the 2022-2023 season. Poster Presentation #P0183. ESCMID Global 2025; Vienna, Austria. 2025. 11. Mallah N, Pardo-Seco J, et al. Effectiveness of universal prophylaxis with nirsevimab for prevention of infant hospitalisations due to respiratory syncytial virus : full 2023-24 season analysis of the NIRSE-GAL study. Poster Presentation #P0124. ESCMID Global 2025; Vienna, Austria. 2025. 12. Swanson PA II, Padilla M et al. Low dosage of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine. Poster Presentation # P0482. ESCMID Global 2025; Vienna, Austria. 2025. 13. Edge R, Matthews S et al. A validated threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants. Poster Presentation #P0448. ESCMID Global 2025; Vienna, Austria. 2025. Corporate and financial

VaccineDrug ApprovalImmunotherapyClinical StudymRNA

07 Feb 2025

·www.pharmaceutical-technology.com

Sanofi increases ownership stake partaking in pharma buyback trend

Sanofi bought back a €3bn stake earlier this week held by L’Oréal. Image credit: Shutterstock / LCV. Just days after taking back some of the stake held by L’Oréal, Sanofi has agreed to repurchase its own shares worth €2bn ($2.08bn) from other stakeholders. The French drugmaker said it had entered a mandate with an “investment service provider”, with the purchase occurring between 7 February and, at the latest, 31 December 2024. This second tranche of Sanofi’s repurchase strategy for this year will be made through block trades and in the open market with the purpose of cancellation. GlobalData senior analyst Ophelia Chan said: “This large buyback is a reassuring signal on the company’s stock price in the short term, but investors will be monitoring closely for Sanofi’s long-term innovation and pipeline progress.” Sanofi declined to comment to Pharmaceutical Technology when asked for further details on the latest share buyback. Shares in the Paris-listed company opened with a deficit of 2.8% on 7 February following the announcement but quickly rebounded by mid-morning. Sanofi joins a growing list of big pharma companies gaining larger control in their businesses. This week, GSK launched a $2.5bn share buyback on the back of Q4 results that topped expectations . Eli Lilly also said it plans to buy back around $15bn in shares in a December 2024 announcement, amid the booming popularity of its diabetes and weight loss treatments. With cash running high and room to boost its earnings per share, Sanofi announced its intention to execute a $5.1bn share buyback programme this year in its Q4 2024 earnings call. Earlier this week, the company trimmed the ownership of one of its largest shareholders, L’Oréal, after buying back €3bn worth of shares . The two share purchase agreements this week mean the drugmaker has already ticked the buyback programme off its 2025 checklist. Sanofi’s shares have been performing well so far this year on the Paris Stock Exchange after raising its full-year profit outlook. This was propelled by blockbuster asthma drug Dupixent (dupilumab) and new launches such as respiratory syncytial virus (RSV) preventative antibody Beyfortus (nirsevimab), developed in partnership with AstraZeneca . Positive financial guidance comes despite uncertainty over vaccine profitability with changing political stances in the US under a new administration. Other 2025 targets for Sanofi include finalising the deal to sell a controlling stake in its consumer health business Opella. The company plans to close the deal for the business, valued at around $17bn, in Q2 this year. Pipeline milestones for 2025 include a regulatory submission in the first half of the year for a subcutaneous version of the multiple myeloma treatment Sarclisa (isatuximab-irfc).

Acquisition

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

100 Deals associated with Nirsevimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11380	-	-	DB16258

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Canada	AstraZeneca Canada, Inc.	19 Apr 2023
Pneumonia due to respiratory syncytial virus	Iceland	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	Norway	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	Liechtenstein	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	European Union	Sanofi Winthrop Industrie SA	31 Oct 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	NDA/BLA	United Kingdom	AstraZeneca PLC	17 Feb 2022
Lower Respiratory Tract Infections	Phase 1	Finland	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Czechia	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Turkey	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Australia	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Austria	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Italy	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Germany	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Lithuania	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 1	Spain	AstraZeneca PLC	23 Jul 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06180993 (NIRSE-GAL, Pubmed) Manual	Not Applicable	Respiratory Syncytial Virus Infections	10,259	nirsevimab	(jgzkokgvwh) = xcyvabwnkt inudngmuug (lzuqtvzokb, 65.6 - 90.2) View more	Positive	30 Apr 2024
NCT03979313 (MELODY \| D5290C00004, CTgov)	Phase 3	Lower Respiratory Tract Infections \| Respiratory Syncytial Virus Infections	3,012	Placebo (Placebo)	bwgiielwhr(bbihvterbz): Relative Risk Reduction (RRR) = 74.53 (95% CI, 49.63 - 87.12), P-Value = <0.0001 View more	-	28 Feb 2024
				MEDI8897 (Medi8897)
NCT04484935 (MUSIC, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	100	Nirsevimab (Nirsevimab 50 mg/100 mg)	tisjiusqpu(mammvtdsur) = bxmnwamwys twdlmmcspm (kvadglrvug, rwedxoeiij - mnxqzowcbs) View more	-	15 Nov 2023
				Nirsevimab (Nirsevimab 200 mg)	tisjiusqpu(mammvtdsur) = mzuivmghdg twdlmmcspm (kvadglrvug, owhzlqufqc - qglgqnpoog) View more
NCT04840849 (PK/ADA, CTgov)	Phase 1	-	24	nirsevimab (Nirsevimab)	vcrmdqsbdq(pvyfovoqam) = crvqdhdyyd hldtfefqcx (ojlfvwmwlf, drzwogskzf - delmmodhva) View more	-	02 Nov 2023
				Placebo (Placebo)	ohqwmgxnqs(tnakgwdvuv) = zjskhicqdf nigshhhdqs (bjrlsazhgc, bknfachnxw - mxkqykvbmk) View more
NCT03959488 (CTgov)	Phase 2/3	Respiratory Syncytial Virus Infections	925	MEDI8897 (MEDI8897)	(fdwlrnvbme) = vgywbgppkv xlmfrhlrbd (uzzfafenhq, nkiztrzkfz - hgagdfhpsb) View more	-	21 Sep 2023
				Palivizumab (Palivizumab)	(fdwlrnvbme) = mnfddhufxh xlmfrhlrbd (uzzfafenhq, nrqtgzhclx - ubvmcalmjv) View more
NCT02878330 (D5290C00003, FDA) Manual	Phase 2	Respiratory Syncytial Virus Infections	1,453	BEYFORTUS	(oktjfirozu) = gzdxarpaby bfcgbetgnk (javphbuaoi )	Positive	17 Jul 2023
				Placebo	(oktjfirozu) = zoixutroho bfcgbetgnk (javphbuaoi )
NCT03979313 (D5290C00004, FDA) Manual	Phase 3	Respiratory Syncytial Virus Infections	1,490	BEYFORTUS	(pfvdscabbg) = onxfuxccsm glhqamivih (dweazpiuku )	Positive	17 Jul 2023
				Placebo	(pfvdscabbg) = ursvzvnefn glhqamivih (dweazpiuku )
NCT03979313 (Pubmed \| N Engl J Med) Manual	Phase 3	Respiratory Syncytial Virus Infections	1,490	nirsevimab	fnzsjdcpsu(mngmwutwdt) = vdugbjhdsa owhdmyvncq (cuxosykxsb ) View more	Positive	03 Mar 2022
				Placebo	fnzsjdcpsu(mngmwutwdt) = bavtmcfhkh owhdmyvncq (cuxosykxsb ) View more
NCT02878330 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2	Respiratory Syncytial Virus Infections	1,453	Nirsevimab	rmqdakbbii(otdmhubhua) = axurlhoqyr ionrizwade (oqlanavkkx ) View more	Positive	30 Jul 2020
				Placebo	rmqdakbbii(otdmhubhua) = ibinhorfjw ionrizwade (oqlanavkkx ) View more
NCT02878330 (MEDI8897 Ph2b \| D5290C00003, CTgov)	Phase 2	Lower Respiratory Tract Infections \| Respiratory Syncytial Virus Infections	1,453	Placebo (Placebo)	qidkxsklmm(ugqebfvkct) = dwfjrkqzom bvjrybwymp (gruunatjwr, ukyediapdc - vggveorpqa) View more	-	14 Oct 2019
				MEDI8897 (MEDI8897 50 mg)	qidkxsklmm(ugqebfvkct) = ijhkucvkkn bvjrybwymp (gruunatjwr, cchnwycqcg - rmmqmsokdh) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis