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.
Environmental Conditions Linked to Health Outcomes for WTC Responders
Review Shows Antihistamines Offer No Meaningful Benefit in Atopic Dermatitis
Most Speakers at FDA Advisory Committee Meetings Support Drug Approval
Countries Involved in U.S. Clinical Trials Do Not Gain Timely Access to Approved Medicines
Once-Weekly Oral Islatravir-Lenacapavir Noninferior to Daily B/F/TAF in HIV
Racial, Ethnic Differences Seen in Inhaler Use for Asthma in U.S. Adults
Nutritional Guidance Lacking for Adults Receiving Semaglutide, Tirzepatide
Zoliflodacin Noninferior for Uncomplicated Urogenital Gonorrhea