FDA to discuss license for anthrax treatment
The FDA's Anti-Infective Drugs Advisory Committee is scheduled to meet in the Washington, D.C., area on November 2 to provide advice and recommendations to the department concerning the biologics license application of raxibacumab, according the U.S. Government Printing Office.
Raxibacumab is a human monoclonal antibody produced by Human Genome Science, Inc. The injection targets anthrax toxins after they are released by the bacteria Bacillus anthracis into blood and tissues. Current antibiotic treatments target the anthrax bacteria itself, according to Business Wire.
The raxibacumab BLA application is a resubmission. In 2009, the FDA asked Human Genome Sciences to further evaluate the histopathology of survivors and non-survivors in animal studies, the potential added benefit of using raxibacumab with antibiotics versus antibiotics alone, and to confirm portions of its previous data.
The meeting is open to the public and the FDA said it intends to make background material available no later than two business days before the committee convenes. Those wishing to speak at the meeting have been advised to contact the FDA no later than October 19.