FDA posts ABthrax briefing documents

FDA posted briefing documents ahead of Tuesday's Anti-Infective Drugs Advisory Committee meeting to discuss a BLA from Human Genome Sciences Inc. (NASDAQ:HGSI) for ABthrax raxibacumab to treat inhalation anthrax. The panel will be asked whether pivotal animal studies support that ABthrax is reasonably likely to have efficacy in humans and whether the benefits outweigh the compound's risk.

FDA also will ask the panel whether further evidence should be requested showing that ABthrax makes a contribution to efficacy when used in combination with an antimicrobial. In the documents, FDA said studies in rabbits and monkeys demonstrated ABthrax was superior to placebo, but ABthrax's contribution to efficacy in two studies in combination with antimicrobials could not be determined due to the antimicrobials' unexpectedly high efficacy. ...