FDA approves Fuzeon (8021)

The Food and Drug Administration on Thursday approved Roche and Trimeris's HIV entry inhibitor Fuzeon, making the drug the first entry inhibitor ever to hit the U.S. market. Trimeris and Roche officials say they plan to begin shipping Fuzeon in late March or early April. The FDA based its approval on an analysis of six months of data from two ongoing clinical trials of Fuzeon involving about 1,000 patients who were experiencing resistance to other anti-HIV medications. The data from this analysis showed that the addition of Fuzeon to a combination of other antiretroviral medications reduced blood-based HIV viral loads.

AIDS activists, however, are anxiously awaiting final word from the drug companies on the cost of the medication. The recent announcement that the drug will cost more than $20,000 per patient per year in Europe has U.S. health care providers and HIV-positive people concerned that the U.S. price will make the drug unaffordable for many low-income, uninsured, or underinsured patients. The expected high cost of the drug also may keep Medicaid programs and state-managed AIDS Drug Assistance Programs from covering it. "We don't think we can add Fuzeon [to our drug list] without cutting something else," Michael Montgomery, head of California's ADAP, told The [Raleigh, N.C.] News & Observer. "We are excited about the drug, but we aren't sure we can afford it." The drug developers say the high cost of the medication is due to its difficult manufacturing process.

Fuzeon, previously known as T-20, is the world's first HIV entry inhibitor. The drug works by preventing HIV from being able to attach to receptors on the surface of T cells, thereby preventing infection. All other existing HIV drugs work by interfering with HIV replication in cells already infected with the virus. The injectable medication was designed as a treatment for patients who have failed other anti-HIV regimens. 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.