AIDS Therapy

European marketing authorization sought for Fuzeon, an HIV fusion inhibitor

Published in AIDS Weekly, December 16th, 2002

Roche and Trimeris, Inc., (TRMS) announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market Fuzeon (enfuvirtide), formerly known as T-20.

Fuzeon is the frontrunner in a new class of anti-HIV drugs called "fusion inhibitors," developed for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Roche and Trimeris have requested priority review status from the FDA, which if granted would enable Fuzeon to be reviewed within 6 months.

In parallel with the filing, Roche and Trimeris confirmed the successful completion of the next major...

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Source: AIDS Weekly (2002-12-16)

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