FDA committee gives nod to GSK anthrax treatment
The FDA's Anti-Infective Drugs Advisory Committee voted unanimously, 18-0, that raxibacumab fits the required risk-benefit profile, and unanimously with one abstention, 16-1, that the treatment is effective, according to MedPageToday.com.
The raxibacumab development program and subsequent regulatory approval were conducted under the FDA's "animal rule," which stipulates that animal test subjects can be used to conduct efficacy studies when studies on humans are unethical or not feasible.
When denied approval in 2009, the FDA expressed doubt about whether or not raxibacumab had added benefits over the antibiotic levofloxacin. GSK's subsidiary, Human Genome Sciences, conducted further studies before the application was resubmitted.
"I don't know how I voted three years ago, but I'm sure I feel better about it today," Dr. Wallace Alston, a committee member, said, MedPageToday.com reports.
The committee's recommendation is non-binding, but an important step towards the FDA's eventual acceptance of any experimental anti-infective medication. GSK's senior vice president and head of infectious diseases, Zhi Hong, said that the decision validates years of work.
"Anthrax has been identified by the US Government as a serious potential threat and there is a need for new treatment options in the event of an anthrax attack in the US," Hong said. "The development of raxibacumab reflects a collaboration of industry and government in response to this public health need, and we are pleased with the outcome of today's meeting which represents years of dedication to this project by Human Genome Sciences."