Japan Approves Insmed’s Brensocatib for Chronic Lung Disease

The approval, announced by Bridgewater-based Insmed Incorporated, clears the once-daily 25-mg tablet for use in adults and pediatric patients aged 12 and older. BRINSUPRI functions as a reversible inhibitor of dipeptidyl peptidase 1, targeting the enzymes responsible for chronic airway inflammation. This decision brings the drug’s regulatory reach to Japan, following its existing approvals in the United States and Europe.

Clinical support for the authorization stems from the Phase 3 ASPEN study. Data showed that patients using the medication experienced a reduction in pulmonary exacerbations and a slower decline in lung function over a 52-week period compared to those on a placebo. While the treatment is designed to mitigate the cycle of infection and tissue damage inherent in bronchiectasis, regulators noted the necessity of monitoring for dermatological, gingival, and periodontal side effects, as well as the avoidance of live attenuated vaccines during the course of therapy.