FDA Panel Finds Animal Models Predict Human Response To HGS Anthrax Drug
Animal model results for Human Genome Sciences' raxibacumab are predictive of the biologics' ability to treat inhalation anthrax in humans, FDA's Anti-Infective Drugs Advisory Committee concluded Oct. 27, but FDA should request more evidence on whether the monoclonal antibody adds benefit to treatment with antibiotics alone
You may also be interested in...
An additional animal study that Human Genome Sciences did after receiving a “complete response” letter from FDA showed clinical benefit for raxibacumab, but with a p-value higher than the standard maximum value of 0.05.
FDA’s Anti-Infective Drugs Advisory Committee will have new pharmacokinetic data to review when it meets Nov. 2 to discuss the monoclonal antibody, which targets the anthrax toxin rather than the pathogen.
When an FDA advisory panel gave its enthusiastic backing to the strategy for anthrax vaccine research developed by the agency's Center for Biologics Evaluation and Research, it also provided an important precedent for future applications of the "animal rule," which allows sponsors to conduct animal trials when human clinical trials would be impractical or unethical.