USA-based Human Genome Sciences has submitted a Biologics License Application to the Food and Drug Administration for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax. The BLA submission includes the results of two randomized placebo-controlled studies conducted in rabbits and monkeys to evaluate the efficacy of raxibacumab. These studies showed a survival benefit in two relevant animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism.
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