Summaries of health policy coverage from major news organizations
Fuzeon to Be Available Free of Charge to Some HIV/AIDS Patients in October
Fuzeon, an experimental antiretroviral drug not yet approved by the FDA, will be available free of charge in October through a compassionate use program to about 1,200 seriously ill HIV-positive people worldwide, the Los Angeles Times reports. 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. Fuzeon, which is also known as T-20 and will be marketed by Hoffman-La Roche and Trimeris, is the first in a new class of drugs, called fusion inhibitors, designed to fight HIV in people who have strains that are already resistant to one or more antiretroviral drugs. Fusion inhibitors work by preventing the virus from entering cells and inserting its viral DNA into the cell's DNA. In two recent studies, Fuzeon, which is taken in conjunction with three to five other antiretroviral drugs, lowered viral loads to undetectable levels in 20% of patients who had already experienced treatment failure with at least one medication. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he expects Fuzeon will reduce viral levels in a higher number of patients once the drug is available to people who are not as sick as those who currently have access to Fuzeon. The drug, which has already been approved for testing and won "fast-track" review status from the FDA, could be on the market as early as the spring, and demand is expected to be high, as "tens of thousands" of HIV-positive Americans are thought to have some form of drug resistance. Heather Van Ness, a spokesperson for Hoffman-La Roche, said that Fuzeon, which has fewer side effects than most antiretroviral drugs but which must be injected twice daily, will most likely be more expensive than HIV medications that are already on the market. Some experts predict that Fuzeon will cost about $12,000 annually (Marsa, Los Angeles Times, 9/16). Hoffman-La Roche and Trimeris officials announced today that they have formally submitted an FDA application for marketing approval of Fuzeon and said that they plan to ask for similar approval for the drug from European Union officials by the end of the month (Associated Press, 9/17).
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