Treats polyneuropathy of hereditary transthyretin-mediated amyloidosis. NDA 217388, held by Astrazeneca AB. Eplontersen Sodium.
As of Nov 13, 2026, NDA 217388 (Wainua (Autoinjector), Wainua), held by Astrazeneca AB, was first approved by FDA on Dec 21, 2023, with 4 approved supplements and 0 published complete response letters.
WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
| Apr 15, 2026 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Wainua (Autoinjector)EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) · solution;subcutaneous | Eplontersen Sodium | RxReference drug |
| WainuaEQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) · solution;subcutaneous | Eplontersen Sodium | RxReference drug |
| Apr 15, 2026 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Apr 18, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Sep 25, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Dec 21, 2023 | 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
