Human Genome Sciences announced that the FDA has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax.
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 vs. antibiotics alone, and additional validation to confirm previous data.
Raxibacumab is a human monoclonal antibody that represents a novel way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by bacteria into blood and tissues.
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