Europe approves Fuzeon, expanded use of Viread

By Advocate.com Editors

Originally published on Advocate.com May 28 2003 11:00 PM ET

The European Union on Tuesday gave marketing approval to drugmakers Roche and Trimeris to sell their HIV fusion inhibitor Fuzeon in all 15 member nations. The drug will cost $20,385 per year in Europe, slightly higher than the U.S. cost. The Food and Drug Administration approved Fuzeon for sale in the United States on March 13. Fuzeon, previously known as T-20, is the world's first HIV fusion inhibitor that works outside immune system cells to prevent HIV from attaching to and infecting the cells. All other available anti-HIV medications work to slow HIV replication inside cells already infected with the virus. Clinical trials showed Fuzeon to help lower blood-based viral loads, even among those carrying drug-resistant virus, when used as part of combination therapy. A Fuzeon follow-up product, called T-1249, is currently in development and has been shown in clinical trials to reduce viral levels in patients who have developed resistance to other anti-HIV medications, including Fuzeon.

The E.U. also expanded its approval of Viread, Gilead Science's nucleotide reverse transcriptase inhibitor. The drug was approved in 2002 for treatment among HIV-positive people who've already taken other anti-HIV medications. The expanded approval allows doctors to prescribe Viread as part of first-time therapy. Viread was approved in the United States in 2001.