Core 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]

Core Insights - The FDA has approved BRINSUPRI (brensocatib) as the first treatment for non-cystic fibrosis bronchiectasis (NCFB), providing a new option for approximately 500,000 diagnosed patients in the U.S. [1][2][3] - BRINSUPRI is a first-in-class DPP1 inhibitor that targets neutrophilic inflammation, addressing a root cause of bronchiectasis exacerbations [1][5][9] - The approval is based on positive results from Phase 3 ASPEN and Phase 2 WILLOW studies, showing significant reductions in exacerbation rates and improvements in lung function [3][11][12] Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on developing first- and best-in-class therapies for serious diseases [1][25] - The company emphasizes a patient-first approach and aims to transform the lives of patients with chronic conditions [1][25] - Insmed is headquartered in Bridgewater, New Jersey, and has a diverse portfolio of approved and investigational medicines [25][26] Product Details - BRINSUPRI is available in 10 mg and 25 mg doses, taken orally once daily, and is now accessible through a specialty pharmacy network [1][6][9] - The drug is designed to inhibit neutrophil serine proteases, which are key drivers of chronic airway inflammation in NCFB [5][9] - The safety profile of BRINSUPRI was evaluated in clinical trials, with common adverse reactions including upper respiratory tract infections and headaches [3][17] Clinical Study Insights - The ASPEN study involved over 1,680 adult patients and demonstrated a 21.1% reduction in exacerbation rates for the 10 mg dose and a 19.4% reduction for the 25 mg dose compared to placebo [3][11] - The WILLOW study included 256 adult patients and focused on the time to first pulmonary exacerbation, further supporting the efficacy of BRINSUPRI [12] - Both studies confirmed the safety and tolerability of BRINSUPRI, with a generally similar safety profile across different patient populations [3][17] Market Potential - The approval of BRINSUPRI is expected to significantly impact the management of NCFB, a condition that affects hundreds of thousands of patients in the U.S. and millions globally [2][3][13] - Insmed plans to file for regulatory approval in Europe and Japan, with commercial launches anticipated in 2026 [6][25] - The introduction of BRINSUPRI may establish a new standard of care for patients suffering from this chronic lung condition [2][3]