Treats infection caused by Orthoebolavirus zairense. BLA 761169, held by Regeneron Pharmaceuticals. Atoltivimab; Odesivimab; Maftivimab.
As of Nov 13, 2026, BLA 761169 (Inmazeb), held by Regeneron Pharmaceuticals, was first approved by FDA on Oct 14, 2020, with 3 approved supplements and 0 published complete response letters.
INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Inmazeb16.7MG/1ML · solution; injection | Atoltivimab; Odesivimab; Maftivimab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2024 | Supplement 11Labeling · Standard review | Approved | |
| May 13, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Sep 29, 2021 | Supplement 2Manufacturing | Approved | |
| Oct 14, 2020 | Original applicationNew molecular entity · Priority 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
