Press release
CHMP Recommends EU Approval of BRINSUPRI™ (brensocatib) for the Treatment of Non-Cystic Fibrosis Bronchiectasis
— If Approved, BRINSUPRI Would Be the First and Only Treatment in the European Union for Non-Cystic Fibrosis Bronchiectasis (NCFB) and the First-in-Class
About this update from Insmed Incorporated
[{"type":"text","content":"\n — If Approved, BRINSUPRI Would Be the First and Only Treatment in the European Union for Non-Cystic Fibrosis Bronchiectasis (NCFB) and the First-in-Class DPPI Inhibitor Targeting Neutrophilic Inflammation\n \n — BRINSUPRI Was Reviewed Under CHMP's Accelerated Assessment Pathway as It Is Considered of Major Interest for Public Health and Therapeutic Innovation —\n \n BRIDGEWATER, N.J., Oct. 17, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of its DPP1 inhibitor 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. If approved, BRINSUPRI would be first-in-class and the first approved therapy in the European Union to treat NCFB.\n \"Non-cystic fibrosis bronchiectasis is a progressive disease that can lead to lung function decline—and with diagnoses rising steadily worldwide, there is an urgent need for additional treatment options,\" said ASPEN lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. \"Based on the clinical benefits demonstrated in the ASPEN and WILLOW studies, brensocatib has the potential to change the treatment paradigm in non-cystic fibrosis bronchiectasis, offering the prospect of significantly improving treatment outcomes for those living with this debilitating illness.\"\n The CHMP opinion is based on a comprehensive scientific evaluation of the marketing authorization application, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. BRINSUPRI was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health and therapeutic innovation. BRINSUPRI had previously been granted Priority Medicines (PRIME) designation by the EMA for the treatment of NCFB following positive Phase 2 study results from WILLOW. The European...