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AIDAC Recommends Approval of GSK’s Anti-Anthrax Drug on Resubmission

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The FDA’s Anti-Infective Drugs Advisory Committee Friday recommended approval of GlaxoSmithKline’s (GSK) 40-mg/kg raxibacumab IV solution, with or without an antimicrobial, to treat adults infected in an airborne anthrax attack. The committee voted 16 to 1 in favor of the drug, with one abstention. All panelists agreed GSK’s animal studies had shown efficacy but one member was concerned the drug’s effect was not proven statistically significant.
Drug Industry Daily