Fuzeon receives FDA fast-track status

By Advocate.com Editors

Originally published on Advocate.com October 16 2002 12:00 AM ET

The Food and Drug Administration has granted fast-track review status to the experimental HIV fusion inhibitor Fuzeon, formerly known as T-20, a move that could make the drug available to the public by mid March. Approval could have taken twice as long without the fast-track review status. The FDA will review the drug no later than March 16. Drugmakers Roche and Trimeris, which jointly developed Fuzeon, filed for FDA review in September.

Fuzeon is the first drug in a new class of HIV antiretrovirals that aim to prevent the virus from being able to attach to and infect immune system cells. The FDA application for the drug seeks approval for patients who are not responding to other anti-HIV medications, but studies have shown that Fuzeon may be even more effective in treating people recently infected with the virus. The drug, which must be injected, is expected to cost between $12,000 and $15,000 per year