Roche and Trimeris Inc announced that Fuzeon (enfuvirtide), a novel treatment for HIV-1, has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) following a six-month priority review. 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.

Fuzeon is the first fusion inhibitor, representing the first new class of anti-HIV treatments in seven years. Unlike all currently approved anti-HIV drugs, Fuzeon blocks the virus from entering the human immune cell, preventing HIV replication that can devastate the immune systems of HIV infected individuals.

"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic," said Dr. Michael Saag, Director, AIDS Outpatient Clinic, University of Alabama at Birmingham. "Patients are becoming resistant to our best therapies and they need new options. This drug attacks the virus in a new way, so it can work for patients whose virus is resistant to other therapies."

Roche and Trimeris have committed to make Fuzeon available for distribution before the end of March. Because initial demand for Fuzeon may exceed supply following commercial availability, Roche and Trimeris have developed and are now finalizing a US Progressive Distribution Plan to provide Fuzeon to patients and to ensure uninterrupted supply to patients once they begin therapy. The details of this US Progressive Distribution Plan will be announced in the near future.

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 analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of Fuzeon of 24 weeks' duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of Fuzeon in antiretroviral naive patients. There are no results from controlled trials evaluating the effect of Fuzeon on clinical progression of HIV-1.

This indication is reflective of a policy shift within the anti-viral division at FDA designed to ensure that indications more closely reflect the patient populations studied.