Insmed Inc announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of Non-Cystic Fibrosis Bronchiectasis (NCFB) in patients aged 12 years of age and older with two or more exacerbations in the prior 12 months. The treatment is a first-in-class therapy, offering the first and only approved treatment to date for NCFB in the European Union (EU). It was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health.

NCFB is a chronic and progressive disease that can lead to permanent lung damage and lung function decline. Unlike other respiratory diseases that are characterised by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. A hallmark of bronchiectasis is frequent exacerbations, or flares, when symptoms—such as coughing, increased mucus, shortness of breath and fatigue—worsen. An estimated 600,000 people in the EU are diagnosed with NCFB, with approximately two million additional people potentially undiagnosed.

"Living with Non-Cystic Fibrosis Bronchiectasis profoundly alters daily life, taking a toll on both physical health and emotional well-being. 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," said James Chalmers, ASPEN lead study investigator, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK.

This approval is based on a comprehensive scientific evaluation of the marketing authorisation application, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking brensocatib 25 mg had a 19.4 percent reduction in annual rate of exacerbations, as compared to placebo.

Brensocatib 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 brensocatib 25 mg experienced statistically significant less decline in lung function, compared to placebo, as measured by Forced Expiratory Volume in one second (FEV?) after using a bronchodilator, at week 52. The safety was also evaluated in both studies. The most frequently reported adverse reactions are headache (9.2 percent), hyperkeratosis (5.9 percent), dermatitis (4.2 percent), rash (4.1 percent), upper respiratory tract infections (3.9 percent), and dry skin (3 percent).

"At Insmed, our mission has always been to bring new therapies to underserved patient communities. With brensocatib, 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. 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," said Martina Flammer, MD, MBA, Chief Medical Officer (CMO), Insmed.

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

Applications for brensocatib are currently under review with the Medicines and Healthcare products Regulatory Agency in the UK and the Pharmaceuticals and Medical Devices Agency in Japan.