Insmed Wins EU Approval For BRINSUPRI, The First Treatment For Non-Cystic Fibrosis Bronchiectasis In Patients 12 Years Of Age And Older With Two Or More Exacerbations In The Prior 12 Months

Author: Benzinga Newsdesk | November 18, 2025 11:03am

— Non-Cystic Fibrosis Bronchiectasis (NCFB) Is a Serious, Progressive Lung Disease That Can Lead to Permanent Lung Damage —

— BRINSUPRI Is a First-in-Disease, First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation —

— BRINSUPRI Was Reviewed Under EMA's Accelerated Assessment Pathway as It Is Considered of Major Interest for Public Health —

BRIDGEWATER, N.J., Nov. 18, 2025 /PRNewswire/ -- Insmed Incorporated (NASDAQ:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today 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.

NCFB is a chronic and progressive disease that can lead to permanent lung damage and lung function decline. Unlike other respiratory diseases that are characterized 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.

Posted In: INSM