FDA Approves Gilead, GlaxoSmithKline Fixed-Dose Combination AIDS Drugs
August 3, 2004
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
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
FDA Approves Two Combination Pills, Epzicom and Truvada; Comment on Commercial Race to Once-a-Day Nucleosides
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