European Commission Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment Approved for Non-Cystic Fibrosis Bronchiectasis in the European Union

Core Insights - The European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older with two or more exacerbations in the prior 12 months, marking it as the first approved treatment for NCFB in the EU [1][4] - BRINSUPRI was reviewed under the EMA's Accelerated Assessment Pathway due to its significant public health interest [1] Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a commitment to underserved patient communities [14][15] - The company is advancing a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [14] Product Details - BRINSUPRI is a small molecule, once-daily oral reversible inhibitor of dipeptidyl peptidase 1 (DPP1), indicated for the treatment of NCFB in patients aged 12 years and older [6] - The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which demonstrated a 19.4% reduction in the annual rate of exacerbations for patients taking BRINSUPRI compared to placebo [3][8] Clinical Study Insights - The ASPEN study involved over 1,680 adult patients and 41 adolescent patients, showing significant improvements in exacerbation rates and lung function [8] - The WILLOW study included 256 adult patients and focused on the time to first pulmonary exacerbation, further supporting the efficacy of BRINSUPRI [9] Market Potential - An estimated 600,000 people in the EU are diagnosed with NCFB, with an additional two million potentially undiagnosed, indicating a substantial market opportunity for BRINSUPRI [2][10] - Insmed plans to engage with EU authorities to secure access to BRINSUPRI for eligible patients starting in early 2026 [4]