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PHARMACEUTICAL
Panel seeks study of Human Genome drug
Human Genome Sciences' experimental drug raxibacumab needs more testing for use against inhaled anthrax, a U.S. panel said.
Outside advisers to the Food and Drug Administration voted 17 to 6 with one abstention to recommend additional studies of the product's benefits compared with antimicrobials such as Johnson & Johnson's Levaquin and Bayer's Cipro. The panel was split on whether more studies were needed to examine if raxibacumab interferes with the other drugs' benefits when given together.
Raxibacumab is Rockville-based Human Genome's first product, and 20,000 doses are stockpiled by the U.S. government in case of a bioterrorist attack. The company received a $151 million order in July for 45,000 more doses and stands to get an extra $10 million from the government if the drug wins regulatory approval.
"We ought to be more certain that it is truly efficacious above and beyond the antibiotics," said Thomas Moore, the panel's chairman and a professor at the University of Kansas School of Medicine in Wichita.
The FDA said in documents posted on its Web site that it decided not to ask its advisers to vote specifically on whether raxibacumab should be approved.
The agency has questions about the reliability of the way Human Genome measured how the drug is broken down by the human body.
The company hopes to resolve the FDA's concerns before the agency is scheduled to decide on the company's application in the middle of next month, said David Stump, executive vice president for research and development.
-- Bloomberg News
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