Gilead, BMS, Merck Antiretroviral Atripla Recommended For Approval

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Antiretroviral Drug Atripla

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A panel of the European Medicines Agency has recommended for approval the once-daily antiretroviral drug Atripla -- which is manufactured jointly by Gilead Sciences, Bristol-Myers Squibb and Merck -- the companies announced on Thursday, Reuters reports (Reuters, 10/18). Atripla is comprised of efavirenz, marketed by BMS and Merck, and the Gilead drugs emtricitabine and tenofovir (AP/Yahoo! Finance News, 10/18).

According to a BMS release, the Committee for Medicinal Products for Human Userecommended that Atripla be approved for HIV-positive adults with aviral load of less than 50 copies per milliliter of blood for more thanthree months on their current combination therapies. The CHMPrecommendation also says that the drug should be used only by adultswho have not experienced virological failure on any prior treatmentregimen or developed significant resistance to any of the drugscontained in Atripla before initiating their first treatment regimen(BMS release, 10/18).

BMS, Merck and Gilead said they expect a full EMA decision on Atripla by the end of this year (AP/Yahoo! Finance News,10/18). If approved, Atripla would be the first once-dailyantiretroviral available to most people living with HIV in the EuropeanUnion (BMS release, 10/18).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.

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