European Fee OKs Brinsupri for Non-CF Bronchiectasis

Brinsupri (brensocatib) is now the primary and solely licensed therapy for non-cystic fibrosis bronchiectasis within the EU for sufferers 12 and older with recurrent exacerbations.

RT’s Three Key Takeaways:

1. First-in-Class Approval – The European Fee has authorised Brinsupri as the primary and solely licensed therapy for non-cystic fibrosis bronchiectasis within the EU for sufferers ≥12 with recurrent exacerbations.
2. Clinically Significant Advantages – Part 3 ASPEN information confirmed that brensocatib 25 mg considerably decreased annual exacerbations, extended time to first exacerbation, improved lung perform decline, and demonstrated a manageable security profile.
3. Main Milestone for Sufferers – The approval marks a serious development for an underserved inhabitants and helps broader international regulatory opinions as Insmed works to safe affected person entry starting in early 2026.

The European Fee authorised Brinsupri (brensocatib 25 mg tablets) for the therapy of non-cystic fibrosis bronchiectasis (NCFB) in sufferers 12 years of age and older with two or extra exacerbations within the prior 12 months, based on producer Insmed Inc.

Brinsupri is a first-in-class remedy, providing the primary and solely authorised therapy to this point for NCFB within the European Union (EU). It was reviewed below accelerated evaluation by the EMA as it’s deemed to be of main curiosity for public well being.²

NCFB is a power and progressive illness that may result in everlasting lung harm and lung perform decline.^{i, iii} In contrast to different respiratory ailments which are characterised by airway narrowing, bronchiectasis causes airways to completely widen, making it more durable to clear mucus and micro organism, resulting in persistent irritation and an infection.^1,3 A trademark of bronchiectasis is frequent exacerbations, or flares, when signs—similar to coughing, elevated mucus, shortness of breath and fatigue—worsen.^4-5  An estimated 600,000 individuals within the EU are recognized with NCFB, with roughly two million extra individuals probably undiagnosed.^6-11

“Residing with non-cystic fibrosis bronchiectasis profoundly alters day by day life, taking a toll on each bodily well being and emotional well-being,” mentioned ASPEN lead examine investigator James Chalmers, MBChB, Ph.D., Professor and Marketing consultant Respiratory Doctor on the Faculty of Medication, College of Dundee, UK. “The European Fee’s approval represents a serious milestone for sufferers and clinicians in Europe, providing a much-needed therapy that may assist scale back exacerbations, probably sluggish illness development, and reshape the therapy panorama for this debilitating illness.”

This approval relies on a complete scientific analysis of the advertising authorization utility, together with information from the Part 3 ASPEN and Part 2 WILLOW research, which had been each revealed within the New England Journal of Medication^.12-13 In ASPEN, sufferers taking brensocatib 25 mg had a 19.4% discount in annual price of exacerbations, as in comparison with placebo.¹² Brensocatib 25 mg additionally met a number of exacerbation-related secondary endpoints, together with considerably prolonging the time to first exacerbation and considerably rising the proportion of sufferers remaining exacerbation-free over the therapy interval.¹² Sufferers who obtained brensocatib 25 mg skilled statistically vital much less decline in lung perform, in comparison with placebo, as measured by compelled expiratory quantity in a single second (FEV₁) after utilizing a bronchodilator, at week 52.¹² The security was additionally evaluated in each research. Essentially the most steadily reported hostile reactions are headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), higher respiratory tract infections (3.9%), and dry pores and skin (3.0%).^12-13

“At Insmed, our mission has at all times been to carry new therapies to underserved affected person communities. With brensocatib, we now have the primary therapy for non-cystic fibrosis bronchiectasis authorised within the European Union—a traditionally ignored inhabitants with long-standing unmet medical wants,” mentioned Martina Flammer, MD, MBA, Chief Medical Officer of Insmed. “The accelerated approval displays the power of the info and the potential to develop into the brand new normal of take care of treating sufferers with non-cystic fibrosis bronchiectasis who had at the least two prior exacerbations. We’re grateful to the sufferers, clinicians and companions who made this milestone attainable.”

The EC approval follows a constructive opinion from the Committee for Medicinal Merchandise for Human Use of the European Medicines Company (EMA) on 16 October 2025. Insmed will have interaction with authorities throughout the EU to safe entry for eligible sufferers starting in early 2026.

Purposes for brensocatib are presently below evaluate with the Medicines and Healthcare merchandise Regulatory Company within the UK and the Prescription drugs and Medical Units Company in Japan.

References from Insmed

1. O’Donnell AE. Bronchiectasis—a medical evaluate. N Engl J Med. 2008;358(9):536–546 final accessed November 2025
2. EMA. First therapy for severe power lung illness. Obtainable at:  accessed November 2025
3. Flume PA, Chalmers JD, Olivier KN. Advances in bronchiectasis: endotyping, genetics, microbiome, and illness heterogeneity. Lancet. 2018 Sep 8;392(10150):880-890. doi: 10.1016/S0140-6736(18)31767-7. PMID: 30215383; PMCID: PMC6173801. final accessed November 2025
4. Chalmers et al. Bronchiectasis in Europe: information on illness traits from the European Bronchiectasis registry (EMBARC). Lancet Respir Med 2023;  Final accessed November 2025.
5. NICE. Bronchiectasis (non-cystic fibrosis), acute exacerbation: antimicrobial prescribing. Obtainable at  Final accessed November 2025.
6. IGES evaluation (2024) of the InGeF claims information in Germany (2017-2022)
7. Cegedim evaluation (2024) of THIN® databases in France (2013-2022)
8. IQVIA evaluation (2024) of the LPD database (2017-2022)
9. Cytel evaluation (2024) of the Massive-Pac database (2017-2023)
10. CRA ‘Market Sizing’ market analysis, January 2023
11. Insmed Evaluation 2022: Potential Undiagnosed or Misdiagnosed (with COPD, Bronchial asthma) BE sufferers in US estimated based mostly on Medical Specialists pushed insights, utilized to Affected person Degree Claims Information
12. Chalmers at al. Part 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med 2025;392:1569-1581 DOI: 10.1056/NEJMoa2411664.  final accessed November 2025
13. Chalmers et al. Part 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med 2020;383(22):2127-2137.  final accessed November 2025