European Commission approves Brinsupri (brensocatib) as the first anctd only treatment approved for non-cystic fibrosis bronchieasis in the EU – Insmed

Insmed  announced that the European Commission has approved  Brinsupri  (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.  Brinsupri  is a first-in-class therapy, offering the first and only approved treatment indicated for NCFB in the European Union (EU).  Brinsupri  was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health.

This approval is based on a comprehensive scientific evaluation of the marketing authorization application, including data from the Phase III ASPEN and Phase II WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking Brinsupri 25 mg had a 19.4% reduction in annual rate of exacerbations, as compared to placebo. Brinsupri 25 mg also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.  Patients who received Brinsupri 25 mg experienced statistically significant less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety of Brinsupri was also evaluated in both studies. The most frequently reported adverse reactions are headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%).

The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the  EMA  on 16 October 2025. Insmed will engage with authorities across the EU to secure access to  Brinsupri  for eligible patients beginning in early 2026.

Applications for brensocatib are currently under review with the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. and the Pharmaceuticals and Medical Devices Agency in Japan.

“At Insmed, our mission has always been to bring new therapies to underserved patient communities. With BRINSUPRI, we now have the first treatment for non-cystic fibrosis bronchiectasis approved in the European Union—a historically overlooked population with long-standing unmet medical needs,” said Dr. Martina Flammer, Chief Medical Officer of Insmed. “The accelerated approval reflects the strength of the data and the potential to become the new standard of care for treating patients with non-cystic fibrosis bronchiectasis who had at least two prior exacerbations. We are grateful to the patients, clinicians and partners who made this milestone possible.”

“Living with non-cystic fibrosis bronchiectasis profoundly alters daily life, taking a toll on both physical health and emotional well-being,” said ASPEN lead study investigator Prof. James Chalmers, Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. “The European Commission’s approval represents a major milestone for patients and clinicians in Europe, offering a much-needed treatment that can help reduce exacerbations, potentially slow disease progression, and reshape the treatment landscape for this debilitating disease.”

See citations- Chalmers JD, Haworth CS et al. Phase 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis”- J.D. Chalmers and Others. N Engl J Med 2020; 383:2127 •  The causal role of neutrophil serine proteases in the pathogenesis of bronchiectasis was studied with brensocatib, an inhibitor of protease activation. Brensocatib therapy resulted in a longer time to the first bronchiectasis exacerbation than placebo

Chalmers JD, Burgel PR et al. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis.  N Engl J Med 2025; 392:1569  DOI: 10.1056/NEJMoa2411664