FDA Grants Tentative Approval of a Three-Component AIDS Drug in Association with the President’s Emergency Plan for AIDS Relief

            On June 30, 2006, the FDA granted tentative approval for a three-ingredient fixed dose tablet for use as a stand-alone antiretroviral treatment for human immunodeficiency virus (HIV-1) in adults.  The product, which is manufactured in India by Aurobindo Pharma Lt., is comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTIs).  The three previously approved, widely used  antiretroviral products contained in the product are lamivudine, zidovudine, and nevirapine.  Fixed dose combination products provide advantages by simplifying the complicated HIV medication regimen to improve patient compliance and eventually minimizing the development of viral resistance.  The product will be available for purchase and distribution in 15 countries; however, existing patents and exclusivity rights prevent approval of the product for use in the Unites States.^1,2

            This approval follows a 2004 FDA guidance encouraging manufacturers to develop fixed dose and co-packaged products consisting of previously approved antiretroviral medications.  The guidance was issued as part of the President’s Emergency Plan for AIDS Relief (PEPFAR).  President Bush first announced this $15 billion plan during his 2003 State of the Union address.  Since 2004, the FDA has approved more than 20 treatments for use under PEPFAR.^1,3

            Since 1981, when the first cases of unusual immune system failure were identified in the United States, treatment of HIV/AIDS has changed dramatically.  The first antiretroviral therapy for AIDS, azidothymidine (AZT), was approved in 1987.  In the mid 1990’s, combination regimens became the mainstay of treatment.  These regimens have included varying combinations of Protease Inhibitors, NRTIs, and NNRTIs.⁴

References: 

1).  www.fda.gov

2).  Aurobindo Pharma Ltd.  http://www.aurobindo.com/

3).  PEPFAR  http://www.state.gov/documents/organization/29831.pdf

4).  Ten Years of HAART http://www.medscape.com/viewarticle/523119

David L. Penix, Pharm.D. Candidate