Food and Drug Administration Grants Priority Status for HIV Drug Fuzeon
October 14, 2002
Hoffman-La Roche Inc. and Trimeris Inc. announced Friday that the US Food and Drug Administration has granted priority-review status to their HIV treatment candidate Fuzeon. Trimeris and Roche submitted a New Drug Application for the enfuvirtide formulation on September 16 after a 24-week study showed the drug, in combination with other antiretrovirals, reduced viral loads in HIV patients, including those whose virus was resistant to other HIV drugs. With the priority designation, the FDA is expected to take action on the application by March 16, Roche said. Injected twice daily, Fuzeon is a fusion inhibitor designed to block HIV from entering human immune cells and is active against HIV that is resistant to the currently available classes of HIV drugs, the companies said.Adapted from:
Wall Street Journal
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.