Budesonide

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

With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication. On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug's accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria. “Today’s approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression, an outcome that matters deeply to patients at risk of long-term kidney damage,” Victor Bultó, Novartis’ US president, said in a release. Backing the approval was data from a phase 3 placebo-controlled trial that showed statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years on Novartis' drug. When done over time, an eGFR blood test can assess kidney functioning and the progress of an IgAN patient. Fabhalta’s first approval in the indication was based on surrogate endpoint data from the same trial, which measured the reduction in patients’ proteinuria (protein in the urine) at nine months versus placebo. That endpoint is an “increasingly recognized surrogate marker correlating with progression to kidney failure,” Novartis said at the time of that readout. Autoimmune kidney disease IgAN is diagnosed in roughly 25 per million people worldwide. Up to 50% of IgAN patients with proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis and/or kidney transplantation, Novartis said. “The ability to significantly slow kidney function decline is a critical treatment goal,” Dana Rizk, M.D., of the Division of Nephrology at the University of Alabama at Birmingham, said in a release. “This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health.” In addition to Fabhalta, Novartis gained an FDA accelerated approval last year for another of its oral medicines Vanrafia, which it picked up in a $3.2 billion buyout of Chinook Therapeutics in 2023. Early this year, the Swiss company said it would seek full approval for the endothelin A (ETA) receptor antagonist, even though it came up short in a phase 3 study assessing kidney function improvement. Novartis is testing its anti-APRIL antibody zigakibart in a phase 3 IgAN study, too. The company amended the trial’s protocol to focus on eGFR and potentially gain a full approval. An interim eGFR readout is expected in the first half of next year. Also on the IgAN treatment landscape are Travere Therapeutics with Filspari, which gained a full approval in the indication in 2024, and Calliditas Therapeutics’ Tarpeyo, which was cleared a year earlier, becoming the first drug to treat the disorder in the U.S. In 2024, Japanese chemical giant Asahi Kasei acquired Sweden-based Calliditas for $1.1 billion. Last year, sales of Fabhalta reached $505 million, which were up 291%. In the first quarter of this year, Novartis reported sales of Fabhalta at $169 million, while Vanrafia chipped in an additional $16 million. Fabhalta originally reached the market in 2023 for paroxysmal nocturnal hemoglobinuria (PNH). Last year, Novartis tacked on an FDA nod for Fabhalta to treat C3 glomerulopathy, as well.