WASHINGTON — Federal advisers said more data is needed to judge the effectiveness of Human Genome Sciences' anthrax treatment compared with existing anti-bacterial drugs, The Associated Press reported Oct. 27.
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.
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.