Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (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.
“We have responded to all of FDA’s previous questions. We plan to address the current questions as well,” said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. “In certain respects, the Complete Response Letter appears to be inconsistent with the FDA’s published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible.”
James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS, and leader of the Company’s raxibacumab program with the U.S. Government, said, “It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA.”