FDA approves raxibacumab (Human Genome Sciences/GSK) to treat Anthrax

The FDA approved raxibacumab injection, from Human Genome Sciences/GSK, on 14 December 2012, to treat inhalational Anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Raxibacumab is the first monoclonal antibody approved under the FDA�s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. In this case, because inhalational anthrax is a rare and lethal disease, it is not possible to conduct adequate efficacy trials in humans.