FDA Clears Insmed’s Brinsupri, First Therapy for Bronchiectasis

The U.S. Food and Drug Administration approved Insmed Inc.’s Brinsupri, or brensocatib, making it the first authorised treatment for non-cystic fibrosis bronchiectasis, a chronic lung disease that affects an estimated 500,000 people in the United States. The oral, once-daily drug is a first-in-class dipeptidyl peptidase 1 inhibitor and is cleared in 10-mg and 25-mg strengths for patients aged 12 and older. Regulators based the decision on results from the 1,721-patient Phase 3 ASPEN study, in which the 10-mg and 25-mg doses cut the annual rate of pulmonary exacerbations by 21.1% and 19.4%, respectively, versus placebo. Both doses also delayed the time to first flare-up and helped more patients remain exacerbation-free, while maintaining a safety profile largely limited to mild skin and gum reactions. Trading in Insmed shares was briefly halted ahead of the announcement and resumed up 5.5%. The company projects Brinsupri could generate as much as $5 billion in peak annual sales. Regulatory applications are already under review in the European Union and the United Kingdom, with a Japanese filing planned for 2025.