Insmed(US:INSM) Prnewswire·2025-10-17 11:00Core Insights - Insmed Incorporated announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of BRINSUPRI (brensocatib) for treating non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older with two or more exacerbations in the past year, potentially making it the first approved treatment for NCFB in the European Union [1][2][3] Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a commitment to transforming patient lives [11][12] - The company has a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [11] Product Details - BRINSUPRI is a once-daily oral DPP1 inhibitor designed to target neutrophilic inflammation, specifically for NCFB treatment [4] - The drug has been granted Priority Medicines (PRIME) designation by the EMA, highlighting its significance for public health and therapeutic innovation [2] Clinical Studies - The CHMP opinion is based on data from the Phase 3 ASPEN study and Phase 2 WILLOW study, both of which demonstrated clinical benefits of brensocatib [2][5][6] - The ASPEN study involved over 460 trial sites across nearly 40 countries, enrolling 1,680 adult patients and 41 adolescent patients [5] - The WILLOW study included 256 adult patients and assessed the efficacy and safety of brensocatib over a 24-week period [6] Market Context - NCFB is a chronic and progressive lung disease affecting approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan, with a rising number of diagnoses globally [7] - Currently, there are no approved therapies specifically targeting bronchiectasis outside the U.S. [7]