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news.Human Genome Sciences (HGS) has submitted Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its human monoclonal antibody drug ABthrax (raxibacumab). The drug will be used for the treatment of inhalation anthrax. It contains the results of two randomized placebo-controlled studies, and also the results of safety studies conducted in healthy human volunteers to assess the efficacy of raxibacumab.
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These studies showed survival benefit in two relevant animal species, which is the minimum requirement for establishing the efficacy of new drugs used in countering bioterrorism.
Raxibacumab is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS).
Sally D. Bolmer, Senior Vice President, Development and Regulatory Affairs, HGS, said: “Based on the results of our efficacy and safety studies, we believe raxibacumab has the potential to be an important new treatment for inhalation anthrax. In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our company.”