BLA 761181, held by Regeneron Pharmaceuticals. Evinacumab-Dgnb.
As of Nov 13, 2026, BLA 761181 (Evkeeza), held by Regeneron Pharmaceuticals, was first approved by FDA on Feb 11, 2021, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2025 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Mar 21, 2023 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 11, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Evkeeza345MG/2.3ML · solution; injection | Evinacumab-Dgnb | Rx |
| Evkeeza1200MG/8ML · solution; injection | Evinacumab-Dgnb | Rx |
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
