FDA Panel Wants More Data on Anthrax Drug
Wed, 10/28/2009 - 4:47am
MATTHEW PERRONE AP Business Writer WASHINGTON (AP) — Federal advisers said Tuesday that more data is needed to judge the effectiveness of Human Genome Sciences' anthrax treatment compared with existing anti-bacterial drugs. The Food and Drug Administration's panel of infectious disease experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs improves the treatment of anthrax. Human Genome Sciences' own studies showed that antibiotic medicines used alone were highly effective against anthrax, raising questions about the added benefit of ABthrax. In a separate vote, the same panel voted 16 to 7, with one abstention, that company studies in rabbits and monkeys could be used to predict how the drug will work in humans. However, the FDA said earlier this week that recent inspections have raised concerns about some of the data submitted in the company's application. As a result, the FDA decided against having its panel vote on whether ABthrax should ultimately be approved. The FDA is not required to follow the panel's vote, though it often does. Rockville, Md.-based Human Genome Sciences has asked the FDA to approve ABthrax to treat anthrax, a bacterial disease caused by contact with a type of highly toxic spore. Inhaled anthrax is the most difficult form to treat and can be fatal. The U.S. government has already ordered more than 60,000 doses of ABthrax for its national emergency stockpile. In 2001, a government scientist mailed letters containing anthrax that ultimately killed five people and sickened 17 others. Since then the U.S. government has bolstered efforts to prepare for potential terrorist attacks involving anthrax and other deadly pathogens.