Treats non-cystic fibrosis bronchiectasis (NCFB). NDA 217673, held by Insmed Inc. Brensocatib.
As of Nov 13, 2026, NDA 217673 (Brinsupri), held by Insmed Inc, was first approved by FDA on Aug 12, 2025, with 0 approved supplements and 0 published complete response letters.
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brinsupri10MG · tablet;oral | Brensocatib | RxReference drug |
| Brinsupri25MG · tablet;oral | Brensocatib | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
