July 23, 2012
The number of antiretroviral drugs tentatively approved or approved for use under the President's Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150.
The Food and Drug Administration has, to date, approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
In addition to generic versions of antiretroviral drugs, FDA has tentatively approved combination products under a 2006 Guidance for Industry, entitled "Fixed Dose Combinations (FDC), Co-Packaged Drug Products and Single Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV." The guidance encourages sponsors to develop various drug product versions of previously approved antiretroviral drugs and to submit drug applications for these products to FDA for review. The availability of a wide range of safe and effective antiretroviral drug products helps to facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic.
Tentative approval means that although FDA has found that a drug product has met all required manufacturing quality, clinical safety, and efficacy requirements, it cannot be approved for marketing in the U.S. at this time because of existing patents and/or marketing exclusivity. However, the product is eligible for purchase outside the U.S. through the PEPFAR program. All FDA reviews of drug applications received in association with PEPFAR are expedited, as are any inspections of the overseas manufacturing facilities.
Established in 2003, the PEPFAR program seeks to prevent, treat, and care for those infected with and affected by HIV/AIDS worldwide. It is a cooperative effort that involves the FDA and other Department of Health and Human Services agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many international partners. PEPFAR represents the largest commitment by any nation to combat a single disease.
"PEPFAR is driven by a shared, global responsibility to save lives affected by HIV and AIDS," said Commissioner Hamburg, M.D. "Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic."
The antiretroviral drug products either fully or tentatively approved by the FDA under PEPFAR include innovative formulations such as fixed-dose combination and co-packaged products that can be used alone as complete regimens or in combination with other antiretroviral drugs. The products also include tablets for adults, as well as tablet formulations that can be dispersed in water for children who are unable to swallow tablets, making it easier for infected individuals to take and adhere to their medications.
The PEPFAR program has supported life-saving antiretroviral treatment for more than 3.9 million men, women, and children worldwide as of Sept. 30, 2011, the most recent figure available. In fiscal 2011, PEPFAR directly supported antiretroviral drug prophylaxis to prevent mother-to-child HIV transmission for more than 660,000 HIV-positive pregnant women, allowing more than 200,000 infants to be born HIV-free.
The FDA approved the first antiretroviral drug in association with the PEPFAR program in 2004.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.
You can view a short video about FDA's role in supporting PEPFAR and the global fight against HIV/AIDS.