Roche and Trimeris Apply for FDA Approval of Fuzeon

Pharmaceutical makers Roche and Trimeris have applied to the FDA for approval of their new antiretroviral drug Fuzeon, the Wall Street Journal reports (Wall Street Journal, 9/18). Fuzeon, formerly known as T-20, is the first in a new class of antiretroviral drugs called fusion inhibitors, which are designed to prevent HIV from entering cells. Fuzeon is designed for patients who have developed drug-resistant strains of the virus and is administered in combination with other antiretroviral drugs. Roche and Trimeris have asked for a six-month priority review for Fuzeon. Priority reviews are typically reserved for "breakthrough treatments for major diseases for which there is no cure" (Associated Press, 9/17). "The introduction of this drug has received great attention, and the need is acute," Dr. John Bartlett, professor of medicine at Duke University Medical Center and an AIDS specialist who oversaw clinical trials of Fuzeon, said (Ranii, Raleigh News & Observer, 9/18). Roche and Trimeris said they hoped Fuzeon would be on the market in the United States by the first quarter of 2003, adding that they plan to apply for marketing approval for the drug in the European Union by the end of the month (Associated Press, 9/17). Analysts say that a year's supply of Fuzeon will cost between $10,000 and $15,000 per patient, a cost that would exceed the prices of most other HIV drugs. Annual sales of Fuzeon are expected to total between $330 million and $660 million (Wall Street Journal, 9/18). Although Fuzeon has not yet received FDA approval, it will be available free of charge in October to approximately 1,200 seriously ill HIV-positive people worldwide through a compassionate use program. Under the program, people with certain life-threatening conditions for which standard treatment is not working can access new medications before they receive FDA approval if their physician is enrolled in the program. About 600 U.S. patients are expected to be able to access the drug through the program (Kaiser Daily HIV/AIDS Report, 9/17).