FDA Approves Gilead, GlaxoSmithKline Fixed-Dose Combination AIDS Drugs
August 3, 2004
FDA 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.
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.