FDA panel recommends raxibacumab for anthrax

FDA's Anti-Infective Drugs Advisory Committee recommended approval of raxibacumab from Human Genome Sciences Inc. to treat inhalational anthrax. The human mAb against Bacillus anthracis protective antigen was developed under the FDA Animal Rule, which allows for marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. The panel voted 16-1, with one abstention, that studies in two animal models showed raxibacumab with or without antimicrobials is reasonably likely to produce a clinical benefit. They also voted 18-0 that results from safety trials in animals and healthy volunteers support an acceptable benefit-risk profile for raxibacumab. ...