The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) issued on Friday the first tentative approval for Aurobindo's three-ingredient fixed dose tablet for use as a stand-alone antiretroviral treatment for human immunodeficiency virus (HIV-1) infection in adults.
The product (lamivudine-zidovudine-nevirapine tablet) contains the active ingredients in the widely used antiretroviral drugs Epivir (lamivudine), Retrovir (zidovudine), and Viramune (nevirapine).
The agency's tentative approval means that although existing patents and/or exclusivity prevent approval of this product in the United States, it meets all of FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the United States.
The fixed-dose combination tablet, manufactured by Aurobindo Pharma, will be available for purchase and distribution in 15 other countries under the President's Emergency Plan for AIDS Relief (PEPFAR).
Dr Scott Gottlieb, FDA deputy commissioner for Medical and Scientific Affairs, said, "Using fixed dose combinations in developing countries may provide an added advantage by improving the patient's ability to tolerate the treatment and better adhere to treatment regimens that will help minimize the development of viral resistance and result in long-term effective control of the disease."
The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two week treatment with the individual components taken individually. Each ingredient of this generic tablet is currently approved to treat HIV-1 infected adults in combination with other antiretroviral agents. The safety and effectiveness of the combination of lamivudine-zidovudine-nevirapine in lowering the viral load and increasing the CD4+ cell has been demonstrated in previously conducted adequate and well controlled studies of the individual ingredients being used together for treatment.
Within the last two years, the FDA has approved more than 20 treatments to be used as part of the PEPFAR program. PEPFAR, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries.
PEPFAR is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.