European Medicines Agency Panel Recommends Approval Of Gilead, BMS, Merck Antiretroviral Atripla

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Oct 2007 - 12:00 PDT

email to a friend   printer friendly   opinions  

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 Use recommended that Atripla be approved for HIV-positive adults with a viral load of less than 50 copies per milliliter of blood for more than three months on their current combination therapies. The CHMP recommendation also says that the drug should be used only by adults who have not experienced virological failure on any prior treatment regimen or developed significant resistance to any of the drugs contained 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-daily antiretroviral available to most people living with HIV in the European Union (BMS release, 10/18).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

• Additional
• References
• Citations