New Anthrax Drug Approved by FDA
March 21, 2016 -- An injectable drug called Anthim (obiltoxaximab) has been approved to treat inhalation anthrax in combination with certain antibiotics, the U.S. Food and Drug Administration says.
The drug was also approved to prevent inhalation anthrax when other treatments are not appropriate or available.
Inhalation anthrax is a rare but dangerous illness that occurs when a person inhales anthrax spores from infected animals or contaminated animal products. It can also occur when anthrax spores are released in a bioterror attack.
"As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax," Dr. Edward Cox, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, FDA, said in an agency news release.
Animal tests showed that the drug improved survival after exposure to anthrax, compared with a placebo. Survival rates were higher when Anthim was used in combination with antibiotics.
The drug's safety was assessed in 320 volunteers. The most common side effects were headache, itching, upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain and the injection site, the FDA said.
Anthim was developed by New Jersey-based Elusys Therapeutics, Inc. and the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority.