FDA panel wants more testing on Anthrax drug

November 4, 2009

On Tuesday, federal advisers stated that more data is needed to judge the effectiveness of Human Genome Sciences’ anthrax treatment. Adding ABthrax, the anthrax treatment, to older drugs may improve the treatment of anthrax. The FDA panel of infectious disease experts voted 17 to 6, with one abstention, that the company should submit more evidence on the effectiveness of adding ABthrax to older drugs.

The FDA panel voted on the use of monkeys and rabbits as tests subjects to predict the effects on humans, it passed.

After recent inspections of the data submitted in the company’s application, the FDA decided against having the panel vote on whether ABthrax should be approved.

60,000 doses of ABthrax have already been ordered by the U.S. government for an emergency stockpile. Although it has not yet been approved the Rockville, Md. -based Human Genome Sciences has asked the FDA to approve ABthrax.

Although the panel for the FDA casts votes, the FDA is also not required to follow the results, it often does though.

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