FDA Approves Gilead, GlaxoSmithKline Fixed-Dose Combination AIDS Drugs

on Monday approved two once-daily, fixed-dose combination antiretroviral drugs manufactured by Gilead Sciences and GlaxoSmithKline, the Bloomberg/Los Angeles Times reports. FDA approved Gilead's Truvada, which combines the company's Viread and Emtriva, and GSK's Epzicom, which combines the company's Ziagen and Epivir (Bloomberg/Los Angeles Times, 8/3). FDA granted priority review status for Truvada in May after Gilead submitted its new drug application on March 12. Gilead had expected a decision by Jan. 12, 2005, based on a traditional review, which usually takes 10 months (Kaiser Daily HIV/AIDS Report, 5/18). However, under the priority review, FDA completed its review of Truvada in four months. FDA approved Epzicom in 10 months, after GSK submitted its NDA in October 2003. HIV/AIDS patients generally take three or more different medications at the same time. Therefore, combination drugs simplify treatment regimens by consolidating different drugs in a single pill. "We gained important scientific knowledge during the development of these products that will be especially useful in our efforts to speed the availability of safe and effective fixed-dose combination products to those who need them in this country and in developing countries under [the President's] Emergency Plan for AIDS Relief program," Dr. Lester Crawford, acting FDA commissioner, said, adding, "Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits" (FDA release, 8/2). Both Truvada and Epzicom were approved for use with other medications.

Drug Costs, Access
Gilead will sell Truvada for $650.83 for a 30-day supply in the United States and will begin shipping the drug to wholesalers by the end of this week, according to Gilead CFO John Milligan. GSK will sell Epzicom for $621.60 for a 30-day supply, Bloomberg/Times reports (Bloomberg/Los Angeles Times, 8/3). GSK said it will issue vouchers for free 60-day supplies of the drug directly to U.S. patients who previously have not used antiretrovirals or need to change their treatment regimens. The vouchers, which are in limited supply, will be issued by health care providers. Truvada and Epzicom gained "speedier" reviews in order to make "safe and effective" drugs available under PEPFAR, according to the AP/Sun Sentinel. By gaining FDA approval, both drugs can now be sold to the Office of the Global AIDS Coordinator in order to distribute the drugs to HIV/AIDS patients in developing countries (Henderson, AP/South Florida Sun Sentinel, 8/3). Gilead said it plans to sell Truvada for 99 cents per patient daily in developing countries within one month, according to Milligan. The company discounted its HIV/AIDS drugs in 68 countries in April 2003 (Bloomberg/Los Angeles Times, 8/3). GSK also said it will sell its drug at not-for-profit prices in developing countries (Reuters/New York Times, 8/3). Ranbaxy Laboratories also announced it will submit to FDA an NDA for a generic fixed-dose combination antiretroviral by the end of the year, making it possible for PEPFAR to distribute the drug in developing countries by next year. AIDS advocates have "push[ed]" for wider access to generic drugs because they are less expensive and easier to use, according to the Wall Street Journal (Lueck/Hamilton, Wall Street Journal, 8/3).

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