Treats inhalational anthrax due to Bacillus anthracis. BLA 125349, held by Human Genome Sciences Inc.. Raxibacumab.
As of Nov 13, 2026, BLA 125349 (Raxibacumab), held by Human Genome Sciences Inc., was first approved by FDA on Dec 14, 2012, with 2 approved supplements and 0 published complete response letters.
Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus 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: The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.2, 14.1 ) There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. ( 1.2, 8.4 ) Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2018 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Raxibacumab1700MG/34ML (50MG/ML) · injectable; iv (infusion) | Raxibacumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2021 | Supplement 26Labeling · Standard review | Approved | |
| Jan 11, 2018 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2012 | 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
