The U.S. Food and Drug Administration has approved Insmed’s Brinsupri, making the oral therapy the first drug specifically cleared to treat non-cystic fibrosis bronchiectasis, a chronic lung disease that permanently damages airways. The decision gives patients, who previously relied on symptom management with antibiotics or surgery, access to a targeted medicine after years without an approved option. Brinsupri, a once-daily dipeptidyl peptidase-1 inhibitor, was backed by the Phase 3 ASPEN study of 1,680 adults and 41 adolescents. In the trial, 10-mg and 25-mg doses cut the annual rate of pulmonary exacerbations by 21.1% and 19.4%, respectively, versus placebo and prolonged the time to first flare-up. Reported side effects included upper-respiratory infections, rash and hypertension. Both tablet strengths will be offered at an identical list price of about $88,000 per year. TD Cowen projects U.S. peak sales of $3.7 billion by 2031, while Insmed estimates the medicine addresses a market of 350,000 to 500,000 diagnosed patients nationally. The stock rose roughly 6% once trading resumed following an initial halt for the announcement. Insmed has filed for approval in the European Union and United Kingdom and plans to submit an application in Japan in 2025. Brinsupri is the company’s second FDA-cleared product, following the 2018 authorization of Arikayce for a rare lung infection.