FDA Approves Anthim for Treating Inhalation Anthrax
Anthim, combined with certain antibacterial drugs, designed to neutralize anthrax toxins
MONDAY, March 21, 2016 (HealthDay News) -- Anthim (obiltoxaximab) has been approved by the U.S. Food and Drug Administration to treat inhalational anthrax.
Anthrax toxins can cause severe tissue damage and death, the FDA said Monday in a news release. Anthim, combined with certain antibacterial drugs, is designed to neutralize the toxins. The medication's effectiveness was evaluated in studies conducted on animals, since it wasn't ethical or feasible to conduct such trials with human volunteers, the agency said.
The drug's safety was evaluated in 320 healthy human volunteers. The most common side effects included headache, pruritus, upper respiratory tract infection, cough, nasal congestion, hives, and injection-site reactions such as swelling, bruising, and pain.
Anthim's label includes a boxed warning of a potential anaphylaxis. "However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to outweigh this risk," the FDA said in a news release.
Anthim was developed by Pine Brook, N.J.-based Elusys Therapeutics, with assistance from the U.S Department of Health and Human Services' Biomedical Advanced Research and Development Authority.