HGS submits ABthrax to FDA

27 May 2009

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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