Insmed announces FDA approval of Brinsupri for NCFB

Insmed (INSM) Incorporated announced that the U.S. Food and Drug Administration has approved Brinsupri, an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. “Brinsupri is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline,” the company stated. In parallel, applications for brensocatib with the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency have been accepted, and the company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. Brinsupri is now available in the U.S. by prescription through a specialty pharmacy network, the company noted.