Key Highlights 

• This European Authorisation reinforces Chiesi’s commitment to provide a broad range of formulations and devices to asthma patients. 
• NEXThaler^® is a dry powder inhaler (DPI), specifically designed for Chiesi’s extrafine formulations. 
• With the addition of the DPI in the asthma indication, Chiesi is moving towards a range of Carbon Minimal Inhalers for asthma and COPD patients, supporting Chiesi’s ambition to reach Net Zero* across its full value chain by 2035. 

Parma, Italy - 31 July 2026 – Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announced that the European Commission (EC) has granted marketing authorisation for its Single Inhaler Triple Therapy (SITT or beclometasone dipropionate, formoterol fumarate, glycopyrronium) medium strength (88/5/9 µg) delivered via the NEXThaler^® device, for the maintenance treatment of asthma in adult patients in the European Union.

The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May 2026.  

With this approval, Chiesi further expands its range of extrafine formulations in asthma, offering a DPI single inhaler triple therapy option for patients whose asthma is not adequately controlled on dual combination therapy. 

“This approval marks an important step forward in our commitment to improving the management of asthma.” said Simon Manners, Vice President, Global Commercial AIR Franchise “By expanding the extrafine SITT range, we aim to support healthcare professionals with more tailored treatment options and help address the needs of patients living with asthma.” 

Asthma is a chronic inflammatory disease affecting an estimated 363 million people worldwide.¹ According to the Global Initiative for Asthma (GINA), uncontrolled asthma is characterised by poor symptom control and/or frequent exacerbations, including those requiring oral corticosteroids or leading to hospitalisation.² Effective asthma management, including appropriate and timely treatment, is essential to achieve symptom control, reduce the risk of exacerbations, and support patients in living active, fulfilling lives.³ 

This approval further reinforces Chiesi’s longstanding expertise in respiratory care and its focus on advancing innovative treatment solutions. 

Availability of Chiesi SITT NEXThaler^® medium strength for asthma will vary across EU countries and will be subject to national regulatory and reimbursement processes.

References 

1. World Health Organization. Asthma [Internet]. Geneva: WHO; 2026 - Available from: https://www.who.int/news-room/fact-sheets/detail/asthma 
2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2025 update. Available from: https://ginasthma.org 
3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2026 update. Available from: https://ginasthma.org 

*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. 

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 verified 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 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.  

For further information please visit  www.chiesi.com 

Press info:  

Vera Valota  

Head of Global Communications, AIR & CARE  

Tel: +44 734 188 99 92  

Email: v.valota@chiesi.com  

Anna Bonisoli Alquati 
Head of Global External Communications 
E-mail: mediarelations@chiesi.com