Human Genome resubmits raxibacumab BLA

US biotech firm Human Genome Sciences (Nasdaq: HGSI), the subject of a hostile takeover bid from GlaxoSmithKline, said yesterday that the US Food and Drug Administration has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.

The FDA has deemed the resubmission a complete, class 2 response to its 2009 complete response letter following a negative advisory panel vote, which requested further analyses of existing data as well as additional information (The Pharma Letter November 2, 2009). 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 previous data.

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 previous data.