HGS announces resubmission for raxibacumab license
The FDA said it considers the resubmission a complete response to its 2009 request for further analysis of existing data and additional information concerning the effects of raxibacumab, according to RTTNews.com.
The BLA resubmission includes an evaluation of the potential added benefit of using raxibacumab with antibiotics versus without antibiotics, additional evaluations of histopathology of animal studies and additional validation of previously confirmed data.
"We look forward to working with the FDA to continue to move raxibacumab through the regulatory review process over the next several months," Dr. Sally D. Bolmer, the senior vice president of development and regulatory affairs for HGS, said, BusinessWire.com reports.
Raxibacumab is a human monoclonal antibody that targets anthrax toxins after the bacteria release them into human blood and tissue. Traditional antibiotics can kill the anthrax bacteria, but are not capable of neutralizing the toxin the bacteria produce.
The Biomedical Advanced Research and Development Authority, which is part of the U.S. Department of Health and Human Services, first entered into a contract with HGS to develop raxibacumab in 2006. Three years later, the company delivered 20,000 doses of the treatment to the U.S. Strategic National Stockpile.