FDA Approves First Therapy Brensocatib for Non-Cystic Fibrosis Bronchiectasis

The FDA has approved Brinsupri (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older, addressing a significant unmet medical need for approximately 500,000 affected individuals in the U.S. Brensocatib is a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor that targets neutrophilic inflammation, the root cause of bronchiectasis exacerbations, and has demonstrated a reduction in annual exacerbation rates by around 20% in clinical trials. The approval was based on positive results from the phase 3 ASPEN trial and the phase 2 WILLOW study, which showed both doses of Brinsupri significantly reduced pulmonary exacerbations and helped prevent lung function decline. The drug is now available by prescription through specialty pharmacies in the U.S., with regulatory submissions under review in Europe and the UK and plans to seek approval in Japan by 2025, aiming for commercial launches in 2026. Experts, including Dr. Doreen Addrizzo-Harris, highlight the approval as a potential paradigm shift for NCFB treatment, emphasizing that Brinsupri is the first therapy to directly address inflammation driving disease progression. Common side effects observed include upper respiratory tract infections, headache, rash, dry skin, and hypertension.