From the FDA’s Medical Countermeasures Initiative (MCMi) News for U.S. Food & Drug Administration (FDA):
Raxibacumab is the first monoclonal antibody approved under FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support Agency 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.
The FDA granted raxibacumab fast track designation, priority review, and orphan product designation. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease.
To see the announcement, click here.