Roche and Trimeris apply for FDA approval of Fuzeon
BY Advocate.com Editors
September 18 2002 11:00 PM ET
Drugmakers Roche and Trimeris on Tuesday applied to the Food and Drug Administration for approval of their new anti-HIV drug Fuzeon, formerly known as T-20, The Wall Street Journal reports. The companies requested a priority six-month review for the compound and hope to have it on the market in the first quarter of 2003. Fuzeon is the drug in a new class of medications called entry or fusion inhibitors, which work outside the body's cells by preventing HIV from attaching to and infecting them. The FDA application requested review for Fuzeon as part of combination therapy to treat HIV infection.
Roche and Trimeris officials say the drug is designed to treat patients whose HIV has become resistant to other antiretroviral drugs. The companies plan to file for European Union approval of the drug by the end of the month. Analysts say that a year's supply of the drug, which must be
injected, will cost between $10,000 and $15,000.