FDA approves BRINSUPRI as first treatment for non-cystic fibrosis bronchiectasis

The U.S. Food and Drug Administration has approved BRINSUPRI (brensocatib) as the first treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older, Insmed Incorporated (NASDAQ: INSM) announced.

The oral, once-daily medication received approval for both 10 mg and 25 mg tablet strengths. Approximately 500,000 people in the United States are diagnosed with non-cystic fibrosis bronchiectasis, a chronic lung disease that causes permanent airway widening and can lead to lung damage.

The approval was based on data from the Phase 3 ASPEN study and Phase 2 WILLOW study, both published in the New England Journal of Medicine. In the ASPEN trial, patients taking BRINSUPRI 10 mg or 25 mg experienced a 21.1% and 19.4% reduction in annual exacerbation rates, respectively, compared to placebo.

BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor designed to reduce neutrophilic inflammation, which contributes to the disease's progression. The medication also significantly prolonged time to first exacerbation and increased the proportion of patients remaining exacerbation-free during treatment.

The most common adverse reactions in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The drug carries warnings for dermatologic adverse reactions, gingival and periodontal adverse reactions, and potential interactions with live attenuated vaccines.

BRINSUPRI is now available through specialty pharmacy networks in the United States. Insmed has submitted applications to European and UK regulatory agencies and plans to file in Japan in 2025, with commercial launches anticipated in 2026 pending approvals.

You May Also Be Interested In

• Aggreko files for proposed IPO
• Weatherford, NCS Multistage set merger election deadline for Aug. 31
• Faraday Future cancels 237,615 warrants from March 2025 financing