The U.S. Food and Drug Administration (FDA) on Friday approved the Anthim injection to treat inhalation anthrax in combination with appropriate antibacterial drugs.
Anthim is also approved to prevent inhalation anthrax when alternative therapies are not available or appropriate.
“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” Edward Cox, director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research, said.
Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. It was approved under the FDA’s Animal Rule that allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
The safety of the treatment was evaluated in 320 healthy human volunteers. Side effects reported include headaches, itching, upper respiratory tract infections, cough, nasal congestion, hives and bruising around the infusion site.
Inhalation anthrax is a rare disease that occurs after exposure to infected animals or contaminated animal products. It is caused by breathing spores of the anthrax bacterium. When inhaled, the bacteria can replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.