6:34 PM
Oct 31, 2012
 |  BC Extra  |  Company News

FDA reviewers: raxibacumab has 'clinically meaningful benefit'

FDA reviewers said raxibacumab from Human Genome Sciences Inc. has a "positive" benefit-risk profile for treating 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 reviewers noted that in pivotal studies in...

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