regulatory
confidence high
sentiment positive
materiality 0.95
Insmed receives FDA approval for BRINSUPRI (brensocatib), first treatment for NCFB
INSMED Inc
- FDA approved BRINSUPRI 10 mg and 25 mg for non-CF bronchiectasis in adults and children ≥12 years.
- Phase 3 ASPEN: 21.1% (10 mg) and 19.4% (25 mg) reduction in annual exacerbation rate vs placebo.
- Approximately 500,000 U.S. patients diagnosed with NCFB; first approved therapy for this condition.
- BRINSUPRI available by prescription via specialty pharmacy; commercial launches in EU/UK/Japan expected 2026.
- Insmed to host investor call today at 12:00 PM ET to discuss the approval.