Anthim (obiltoxaximab) has been approved by the U.S. Food and Drug Administration to treat inhalational anthrax, a rare disease stemming from infected animal products. Bacillus anthracis spores also pose a deadly bioterrorism threat if released intentionally.
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, itching, upper respiratory tract infection, cough, nasal congestion, hives and injection-site reactions including swelling, bruising and pain.
Anthim’s label includes a boxed warning of a potential severe and possibly fatal allergic reaction known as anaphylaxis. “However, given that anthrax is a very serious and often deadly condition, the benefit for treating anthrax is expected to outweigh this risk,” the FDA said.
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.
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