FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President’s AIDS Relief Plan

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, today granted tentative approval for nevirapine tablets, indicated for use with other antiretroviral agents for the treatment of HIV-1 infection, and for the pediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine -- the first fixed dose anti-HIV product designed to treat children under the age of 12 years. These two drugs mark the 50th and 51st AIDS drugs approved or tentatively approved for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).

The fixed dose combination comprises a complete HIV regimen that is taken twice daily and can be used once patients have tolerated 14 days of lead-in treatment with nevirapine taken once daily. The tablet combination can also be dissolved in water for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet and that this tablet can be stored, distributed, and administered easily to children is a significant advance in the treatment of children infected with HIV in PEPFAR countries.

“The 50th and 51st approvals by the FDA of essential anti-HIV products under the President’s Emergency Plan for AIDS Relief bolsters the commitment made by President Bush to ensure the rapid delivery of unprecedented amounts of safe, effective, and quality drugs, at a lower cost, to help those most in need,” said HHS Secretary Mike Leavitt in marking the milestone.

Today’s approvals under the PEPFAR process are part of the President’s five-year, $15 billion effort to fight the HIV/AIDS pandemic around the world – the largest commitment ever by a single nation toward an international health initiative. As of March 31, 2007, PEPFAR supported life-saving antiretroviral treatment for over 1.1 million men, women and children in the Emergency Plan’s 15 focus countries in sub-Saharan Africa, Asia and the Caribbean.

Nevirapine tablets, and the triple fixed dose combination of lamivudine, stavudine and nevirapine, and 46 other drugs are “tentatively approved” generic drugs (or drug combinations) that have been evaluated by the FDA as part of the PEPFAR program, but which are not available for sale in the United States because of existing patent protection or other U.S. marketing protections. Three other drugs evaluated by FDA as part of this program have been approved for marketing in the United States because they do not have any existing patent or other U.S. marketing protections.

FDA’s tentative approval means that, although existing patents and/or marketing exclusivity prevent the approval for sales of the product in the United States, the product meets all of FDA’s manufacturing quality and clinical safety and efficacy requirements - thus helping to ensure that AIDS patients abroad who receive these medications get the same quality of medications as Americans.

All 51 of the drugs can be purchased outside the United States by PEPFAR partners using U.S. taxpayer dollars.

HHS and FDA are part of a multi-agency effort led by the Office of the Global AIDS Coordinator to accomplish PEPFAR’s initial five-year goals of supporting treatment for 2 million HIV-infected people, prevention of 7 million new infections, and care for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children. On May 30, President Bush announced his intention to work with Congress to reauthorize PEPFAR for five additional years.

“Support for antiretroviral treatment is more than just drugs – it is a sign of hope,” said Ambassador Mark Dybul, the U.S. Global AIDS Coordinator. “It reflects the idea that President Bush has stated so well -- that where you live should not determine if you live or die from HIV/AIDS.”

In 2004, FDA implemented an expedited PEPFAR application review process for individual antiretroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The process includes an FDA commitment to work closely with manufacturers before they submit a marketing application to the FDA, especially those who have never previously submitted marketing applications, and to conduct a priority assessment of those applications.

“The FDA has helped save lives by making these much-needed, high-quality, generic drugs for AIDS available for patients in countries served by PEPFAR,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “In addition, our goal is to assure that drugs purchased by PEPFAR meet the same safety, efficacy, and manufacturing standards as drugs used in the United States.”

PEPFAR remains committed to funding the purchase of the lowest-cost ARVs, whether they are innovator or generic drugs, as long as the medications have been demonstrated to be safe, effective, and of high quality. PEPFAR purchases also must be consistent with international law.

As part of the PEPFAR initiative, FDA is collaborating with the World Health Organization’s Prequalification Program (WHO/PQ). As a result of this collaboration, FDA approved or tentatively approved antiretroviral drugs are placed on the WHO Prequalification Program. This is a program many countries with developing economies use to guide their purchasing of drug products from specific manufacturers so that they can be assured they are purchasing quality medicinal products.

“The countries of the world that depend on the WHO Prequalification Programme to help them purchase quality products have benefited immensely by this cooperation between the FDA and the WHO,” said Dr. Howard Zucker, WHO Assistant Director General for Health and Pharmaceuticals. “Assuring the quality of products like this one made especially for children in developing economies is a major cornerstone of our battle against the HIV epidemic and of our effort to help assure children have access to quality medicines.”

In addition, HHS and FDA continue to work to strengthen the knowledge and training of in-country, national drug regulatory authorities in the PEPFAR focus countries, alone and in collaboration with each other, so that they can better ensure the quality of the medical products available to their citizens.