Treats inhalational anthrax due to B. anthracis. BLA 125509, held by Elusys Therapeutics Inc. Obiltoxaximab.
As of Nov 13, 2026, BLA 125509 (Anthim), held by Elusys Therapeutics Inc, was first approved by FDA on Mar 18, 2016, with 2 approved supplements and 0 published complete response letters.
ANTHIM is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Limitations of Use ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. ( 1.2, 5.1 ) The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2016 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Anthim600MG/6ML · injectable;injection | Obiltoxaximab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Oct 20, 2016 | Supplement 1Manufacturing | Approved | |
| Mar 18, 2016 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
