Human Genome Sciences, Inc. (HGSI) announced that the U.S. Food and Drug Administration, or FDA, has acknowledged receipt of the resubmission of the Biologics License Application, or BLA, for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act action date.
The company stated that the FDA has deemed the resubmission a complete, class 2 response to its November 14, 2009 complete response letter, which requested further analyses of existing data as well as additional information. The BLA resubmission contains additional evaluation of histopathology of survivors and non-survivors in animal studies, evaluation of potential added benefit of using raxibacumab with antibiotics versus antibiotics alone, and additional validation to confirm prior data.
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