FDA grants traditional approval for Fuzeon (enfuvirtide), to treat HIV

Roche and Trimeris today announced that the U.S. Food and Drug Administration (FDA) has granted traditional approval to Fuzeon (enfuvirtide), the first and only fusion inhibitor for the treatment of HIV.

The FDA granted accelerated approval to Fuzeon on the basis of 24-week data in March 2003; accelerated approval is a special regulatory status designed to expedite the approval of therapies for serious or life-threatening illnesses which provide meaningful benefit to patients over existing treatments. The traditional approval of Fuzeon was based on results from Phase III clinical trials over 48 weeks which confirmed the durable efficacy and safety of Fuzeon-based regimens.

"The 48-week data confirm that enfuvirtide-based regimens substantially improve virologic and immunologic outcomes in treatment experienced patients after approximately one year of therapy. Forty-six percent of patients on enfuvirtide-based regimens achieved a significant reduction in HIV levels, compared to 18 percent of patients taking previous standard of care regimens. These strong results establish enfuvirtide as an invaluable component of therapy for triple-class experienced patients who require a change in regimen," said Joel Gallant, M.D., M.P.H., Associate Professor of Medicine and Epidemiology, Division of Infectious Diseases, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

"The traditional approval of Fuzeon further confirms its importance as a crucial option for treatment-experienced HIV patients," said Steven D. Skolsky, CEO, Trimeris. "Together with our partner Roche, Trimeris is proud to reach this important milestone for Fuzeon. The significance of this milestone is further reinforced by data recently presented at the XV International AIDS Conference (IAC), which show that Fuzeon is not only potent, but durable over 96 weeks."

Fuzeon in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on results from two controlled studies of 48 weeks duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of Fuzeon in antiretroviral naove patients.

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