Formoterol Fumarate

Key Highlights Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe . Transition to HFA‑152a , a next‑generation propellant classified as non‑PFAS* and with low global warming potential (GWP) , aims to reduce the carbon footprint of Chiesi’s pMDIs by up to 90% compared to current ones. 1-3 Designed for a seamless transition for patients and HCPs , maintaining established efficacy, safety and usability and supporting continuity of care. 4-8 The validation supports Chiesi’s ambition to reach Net Zero † across its full value chain by 2035 9 , following MHRA approval of Chiesi’s beclometasone pMDIs formulated with HFA-152a. PARMA, Italy--(BUSINESS WIRE)--Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announces a further step in its Carbon Minimal Inhaler (CMI) journey with the validation of regulatory submissions in Europe for its SITT and ICS/LABA pMDIs. The start of regulatory assessment in Europe marks a significant step towards Chiesi’s transition to carbon minimal pMDIs across its respiratory portfolio, combining innovation with responsibility. This supports the Company’s broader ambition to reduce the environmental impact of respiratory care, while enabling a seamless transition for patients and healthcare professionals. In July 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Chiesi’s beclometasone pMDIs formulated with HFA-152a, marking the first UK approval of this next-generation propellant in a pressurised metered-dose inhaler. Chiesi’s pMDIs are transitioning to HFA-152a, a next-generation propellant classified as non-PFAS* and with low-GWP, designed to reduce the products’ carbon footprint by up to 90% compared with current ones 1-3 , while maintaining established efficacy, safety, and usability. 4-8 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Innovation in patient care and environmental responsibility are not a trade-off. Our next-generation carbon minimal pMDIs provide the same level of care , while reducing emissions of up to 90% compared to the ones in use today and at the same level of dry powder inhalers (DPI),” said Andrea Bizzi, Executive Vice President, Region Europe TOP 5 & Interim AIR Franchise. “These submissions are another step on our progression towards a full extrafine CMI portfolio across pMDIs and DPIs.” “The transition to carbon minimal pMDIs is not only a critical step in reducing the environmental impact of respiratory care,” said Sara Panigone, Senior Director, Global Project Leader AIR Franchise, “but also helps to guarantee the long-term availability of a full range of effective inhaled medicines, protecting patient lives, ensuring access and continuity of care.” Chiesi’s CMI portfolio transition is focused on reducing the carbon footprint associated with pMDIs, which remains an important option in asthma and COPD care. Transitioning our pMDIs to the next‑generation propellant HFA-152a, supports the decarbonization of respiratory care while helping to safeguard access and continuity of care over the long term. 1-8, 10-12 * PFAS: per- and polyfluoroalkyl substances, non-PFAS means also non-forever chemical ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Notes to Editors - Regulatory procedures Single Inhaler Triple Therapy (SITT or ICS/LABA/LAMA, beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide) pMDIs have been submitted under the EU centralized procedure to the European Medicines Agency. ICS/LABA (beclometasone dipropionate/formoterol fumarate dihydrate) pMDIs are being managed through a coordinated multi-country regulatory procedure with BfArM – the German Federal Institute for Drugs and Medical Devices - acting as Reference Member State. †Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties. The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions. ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France, and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); For further information please visit References: Panigone S et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment ( ) EU ECHA Webinar: Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH OECD Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances 2021 Rony F et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. ( ) Almeida M et al. Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant. Thorax 2025 BTS Winter meeting Salvadori M et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance ( ) Singh D et al 2026, Respiratory Medicine : Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study ( ) Matturro A et al 2025, An Official Journal of the American Association of Pharmaceutical Scientists: Innovative drug development approach to address the transition to low global warming potential propellant using hydrofluoroalkane‑152a, for triple combination pressurized metered‑dose inhaler products targeting small airways ( ) Chiesi’s Sustainability Report 2025 Pernigotti D et al 2021, BMJ Open Respiratory Research: Reducing carbon footprint of inhalers: analysis of climate and clinical implications of different scenarios in five European countries ( ) Attar-Zadeh D et al 2021, Journal of Health Economics and Outcomes Research: Health-care Resource Requirements and Potential Financial Consequences of an Environmentally Driven Switch in Respiratory Inhaler Use in England ( ) Usmani O et al 2022, Journal of Allergy Clinical Immunology Practice. Real-World Impact of Nonclinical Inhaler Regimen Switches on Asthma or COPD: A Systematic Review. ( ) Contacts Press info: Vera Valota Head of Global Communications, AIR & CARE Tel: +44 734 188 99 92 Email: v.valota@chiesi.com

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