Treats extravascular hemolysis (EVH). NDA 218037, held by Alexion Pharms Inc. Danicopan.
As of Nov 13, 2026, NDA 218037 (Voydeya), held by Alexion Pharms Inc, was first approved by FDA on Mar 29, 2024, with 1 approved supplement and 0 published complete response letters.
VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2025 | Supplement 4REMS | Approved | |
| Mar 29, 2024 | Original applicationNew molecular entity · Standard review | Approved |
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
