Human Genome Sciences, Inc. (HGSI) said it has received a Complete Response Letter from the U.S. Food and Drug Administration relating to the Company's Biologics License Application, or BLA, requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.
Raxibacumab is a first-in-class treatment for anthrax, and the first procurement under Project BioShield of a product discovered and developed after the September 11, 2001 terrorist attacks.
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