Treats acute attacks of hereditary angioedema (HAE). NDA 219301, held by Kalvista. Sebetralstat.
As of Nov 13, 2026, NDA 219301 (Ekterly), held by Kalvista, was first approved by FDA on Jul 3, 2025, with 0 approved supplements and 0 published complete response letters.
EKTERLY is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ekterly300MG · tablet;oral | Sebetralstat | 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
