AIDS Therapy

Fusion inhibitor granted priority review status by FDA

Published in AIDS Weekly, November 11th, 2002

Roche and Trimeris, Inc., (TRMS) announced that the U.S. Food and Drug Administration (FDA) has notified the companies that the New Drug Application (NDA) for Fuzeon (generic: enfuvirtide, formerly known as T-20) is fileable and has been granted priority review status.

Designed for the treatment of HIV-1 in combination with other antiretroviral agents, Fuzeon is the most clinically advanced in an investigational class of anti-HIV drugs called "fusion inhibitors."

The priority review designation establishes a target 6-month review period for the Fuzeon NDA, which was submitted by Roche and Trimeris on September 16, 2002. The FDA will, therefore, take...

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Source: AIDS Weekly (2002-11-11)

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