Human Genome Sciences, Inc. receives approval for anthrax treatment

A Complete Response Letter has been sent to Human Genome Sciences, Inc., from the U.S. Food and Drug Administration about HGS' request for the approval of its treatment for inhalational anthrax.

Complete Response Letters are issued by the FDA to request additional information needed to complete the review of a Biologics License Application request for approval.

We have responded to all of FDA's previous questions. We plan to address the current questions as well," said Sally D. Bolmer, senior vice president of development and regulatory affairs at HGS, said. "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."

HGS says its new new anthrax treatment, raxibacumab, is a new way of addressing the anthrax threat. Antibiotics are effective in killing the anthrax bacteria but are not effective against the deadly toxins that are created by the anthrax bacteria. To fight that, raxibacumab targets the anthrax toxins once they are released by the bacteria into the blood and tissues.

Raxibacumab, a first-in-class treatment for anthrax, is the first procurement under Project BioShield of a product discovered and developed after the terrorist attacks of September 11, 2001. Raxibacumab is being developed under a 2006 contract with the U.S. Department of Health and Human Services'  Biomedical Advanced Research and Development Authority of the Assistant Secretary for Preparedness and Response.

"It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed," James H. Davis, executive vice president and general counsel of HGS, said. "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."