FDA Approvals of 2012

32 of 39


Drug: Raxibacumab
Generic molecule: raxibacumab
Company: GlaxoSmithKline (via Human Genome Sciences)
Approval date: Dec. 14

The scoop: The FDA's approval of the raxibacumab injection marked the first monoclonal antibody approved under the FDA's Animal Efficacy Rule, which allows findings from animal trials when it's not possible or ethical to conduct human studies, as in this case. Raxibacumab is approved to treat inhalational anthrax which is caused by breathing in spores of the bacterium Bacillus anthracis. The drug works by neutralizing the toxins that can lead to tissue damage and death.