FDA Approves New Treatment for Inhalation Anthrax — Physician’s First Watch
FDA Approves New Treatment for Inhalation Anthrax
By Kristin J. Kelley
Obiltoxaximab injection (marketed as Anthim) has been approved in the U.S. to treat inhalational anthrax. It should be taken in combination with antibacterial drugs. It can also be used for preventing the disease when no alternatives are available.
Approval for the monoclonal antibody was based on animal trials, says the FDA, because it wasn't possible to conduct efficacy studies in humans. Survival outcomes were higher when obiltoxaximab was combined with antibacterial therapy, compared with antibacterial treatment alone.
The drug's safety was studied in some 320 human volunteers — it carries a boxed warning about the risk for anaphylaxis and other allergic reactions. Common side effects included bruising, headache, injection-site pain, itching, respiratory tract infections, swelling, cough, and congestion.