Budesonide/Formoterol Fumarate Dihydrate

AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan,is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist (LAMA). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the ​KALOS and LOGOS Phase III trials, in which Trixeo demonstrated statistically significant improvements in lung function ​compared with combined ICS/LABA comparators.1 In the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year.1 Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Across Europe, millions of people with asthma still experience reduced lung function, breathing difficulties, exacerbations and significant disruption to daily life due to uncontrolled disease. The CHMP positive opinion for Trixeo represents an important step forward, offering a potential new treatment option that could help reduce exacerbations and improve disease control for patients living with asthma independent of their prior exacerbation history.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease. The continued momentum of Trixeo across both asthma and COPD reflects our ambition to help transform respiratory care by delivering meaningful improvements in treatment outcomes by reducing the risk of exacerbations for patients.” In a key secondary endpoint, Trixeo demonstrated a rapid onset of action with a significant improvement from baseline in lung function within five minutes after the first dose.1 Trixeo is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.1 There were no new safety or tolerability signals identified for Trixeo in the trials.1 In Europe, there are nearly 43 million people living with asthma, and every year, about four million more people are newly diagnosed.2 When uncontrolled on dual therapies, patients can often struggle with symptoms such as wheezing, breathlessness, coughing exacerbations and even death.3-5 Trixeo/Breztri, is approved in the US for treatment of asthma, with regulatory filings currently under review in other major regions, including Japan and China. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide,including nearly 43 million people in Europe.2,6 Around half of patients continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death.3-5 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.4,5 KALOS and LOGOS Phase III trials KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of Breztri/Trixeo Aerosphere compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: Symbicort pressurised metered-dose inhaler (pMDI) and PT009 (in an Aerosphere formulation).1,7,8 KALOS and LOGOS included approximately 4,300 randomised patients.7,8 In the data package submitted to the EMA, in the individual trials, the primary lung function endpoint was change from baseline in morning pre-dose trough FEV1 over 24 weeks, and the key secondary endpoint was change from baseline in FEV1 AUC0-3 over 24 weeks, versus dual therapy (the ICS/LABA treatment groups combined).1 The pooled primary endpoint using data from both KALOS and LOGOS trials, and prioritised in the testing procedure, was the rate of severe asthma exacerbations versus dual therapy (ICS/LABA) treatment groups combined.1 The primary and secondary endpoints and treatment comparisons in the KALOS and LOGOS trials differed according to regulatory submission approaches.1 Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate or budesonide/glycopyrrolate/formoterol fumarate, is approved under the brand name Breztri Aerosphere in Japan, China and the US, and Trixeo Aerosphere in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the Aerosphere pMDI. Breztri/Trixeo is approved in the US to treat asthma in patients 12 years of age and older. Regulatory filings for Breztri/Trixeo in asthma are currently under review in all other major regions. Breztri/Trixeo is also approved for the treatment of COPD in more than 90 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 6.8 million patients globally in 2025.9 AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, 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 Corporate and financial

Even as trial setbacks and pipeline adjustments rear their heads, AstraZeneca feels confident that its core business is on track to support the $80 billion revenue goal it’s set for 2030. And on the more existential topics of China competition, U.S. drug pricing reform and the potential need for an external pipeline refresh, AZ’s top brass is keeping its cool. In 2026’s second quarter, the British Big Pharma generated revenue of nearly $15.4 million, growing 5% over the same period in 2025 at constant exchange rates. With the first act of 2026 now in the books, AZ is reporting total revenue of $30.7 billion, up some 6%, driven primarily by sales in oncology, rare disease and respiratory and immunology, which each grew over the first half of the year, even as total biopharma earnings dropped for the six-month period thanks to a hit in infectious disease. Among the high-grossing cancer unit, TKI lung cancer med Tagrisso remained AZ’s top earner with Q2 sales of $1.94 billion and a first-half-of-2026 haul amounting to nearly $3.8 billion, followed closely by PD-L1 blockbuster Imfinzi, which brought home $1.85 billion and $3.55 billion for Q2 and the first six months of 2026, respectively. Major multi-billion-dollar sales hauls for the second quarter and first half of the year were also posted by Farxiga in AZ’s cardiovascular category, plus Symbicort and Fasenra in the respiratory and immunology segment and Ultomiris from the rare disease portfolio, with the latter drug growing 12% to $1.31 billion for the quarter. While an improvement year-over-year, that performance fell short of analysts' expectations by around $24 million, according to a note from Jefferies Monday. Adding to that dent in Ultomiris’ quarterly report card, AZ revealed early Monday that a phase 3 trial pitting the drug against placebo in teens and adults with thrombotic microangiopathy after hematopoietic stem cell transplant had failed to hit statistical significance on the primary endpoint of event-free survival through 26 weeks. Thrombotic microangiopathies (TMAs) are rare and potentially lethal disorders that cause blood clots and damage to the walls of the smallest blood vessels in the circulatory system, and AZ had been testing Ultomiris in a type of the condition that occurs after hematopoietic stem cell transplant to treat cancer and other diseases. Still, AZ noted that its Alexion rare disease unit has nevertheless seen clinically meaningful results around overall survival in its pediatric trial and continues to advance filings on Ultomiris in that indication. The Ultomiris slip follows other phase 3 misses from AZ drugs in the period, including for Imfinzi in adjuvant hepatocellular carcinoma and Wainua in ATTR-CM. Separately, AZ revealed in its earnings report that it has scrapped two in-house antibody-drug conjugate (ADC) candidates that underperformed in the clinic. Nevertheless, executives told Fierce on a media call earlier Monday that they remain “very confident” in the company’s roster of investigational ADCs overall. When pressed on an analyst call whether AZ needs to lean on M&A activity to bolster its late-stage pipeline—especially as the company heads for a significant patent expiration period early in the next decade—CEO Pascal Soriot said in no uncertain terms that “the answer is no: We don’t need more BD to deliver.” Soriot emphasized that his confidence doesn’t come from any one single asset but the company’s phase 3 pipeline in aggregate, noting that AZ tracks its overall chance of phase 3 success at “around 60%,” which he noted was a bit lower than the industry average and below AZ’s historic track record of “75%-plus.” “The reason we don’t need more BD is really to continue planning long-term and continuously strengthen our franchises,” the CEO explained, pointing to Tagrisso as one example of a product worth investing in internally rather than rushing out to acquire a new asset. AstraZeneca’s overall second quarter earnings were in line with expectations, the Jefferies analysts pointed out Monday, noting that outsized Q2 performances from hypophosphatasia drug Strensiq (up 36% at $536 million) lymphoma and leukemia med Calquence (up 16% $1.02 billion) and asthma treatment Tezspire (up 45% $390 million) helping counter misses from Tagrisso and Lynparza, as well as AZ’s asthma rescue inhaler Airsupra ($50 million Q2), which “continues to lag,” in the Jefferies team’s estimation. With less than six months to go before the year is out, AZ is sticking to the previous guidance range, which anticipates a mid-to-high single-digit percentage revenue increase over 2025 at constant currencies. Moreover, the company reiterated that it’s confident in the $80 billion revenue target it has pledged to deliver in 2030. In reflecting on Tagrisso, Soriot also touched on the matter of China, where AZ has continued to commit resources heavily even as hawkishness around competition with the country mounts in places like the U.S. But in the CEO’s estimation, this deep relationship is exactly what positions AstraZeneca well to compete as the international biopharma landscape continues to evolve. “If you don’t have a very strong domestic business from a profit viewpoint, it’s not that simple to globalize,” Soriot said of the current China biotech dynamic. “But you have to assume they will at some point.” “What we’re doing,” he continued, “is collaborating, but we’re also competing. You saw the competition in the Tragrisso market is very, very intense, and in the ADC market very intense too. So, we learn to compete with them, and certainly we’ll take those learnings globally when they become global companies, if they do.” Soriot added that “We’re also learning from [China biotechs] in terms of how they develop products and how fast they operate. And we’ve made some changes in the way we operate.”