Insmed Incorporated (Nasdaq: INSM), a US-based global biopharmaceutical company, announced on Tuesday that the US Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

BRINSUPRI is the first and only FDA-approved treatment for NCFB, giving patients and clinicians across the US an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline.

This approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. Both BRINSUPRI dosage strengths met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.

BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. BRINSUPRI is the first approved therapy to address the underlying inflammatory process of NCFB.

In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) 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 US by prescription.