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The Food and Drug Administration has approved Atripla Tablets, a fixed-dose combination of three widely used antiretroviral drugs in a single tablet for the treatment of HIV-1 infection in adults. Atripla is to be taken once a day alone or in combination with other antiretroviral products.
Atripla, the first one-pill, once-a-day product to treat HIV/AIDS, combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine), and Viread (tenofovir disoproxil fumarate). Bristol-Myers Squibb Co. and Gilead Sciences Inc. have formed a joint venture to commercialize Atripla in the United States. The collaboration is the first of its kind in the field of HIV/AIDS. In certain territories, Merck & Co. Inc. holds the rights to Sustiva. All three companies will work together to ensure the product is available to patients and physicians.
Atripla will be available for use in the United States as a new product approved under a new drug application. This designation will allow the drug to be considered for purchase for use in 15 other countries included in the President's Emergency Plan for AIDS Relief (PEPFAR).
Atripla's approval in July 2006 took less than three months and is the result of an expedited review process outlined in a guidance for industry from the FDA in May 2004. The FDA has now approved seven co-packaged or fixed-dose combination products since the guidance was issued.
Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., calls the approval "a significant example of drug developers and FDA clearing the way to quickly deliver quality, lifesaving HIV/AIDS drugs to people who desperately need them in the United States and abroad."
The FDA approved Sustiva in 1998, Viread in 2001, and Emtriva in 2003. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48-week clinical study with 244 adults affected with HIV-1 receiving the drugs contained in Atripla. In the trial, 80 percent of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells—cells that fight against infection.
Atripla's labeling includes a boxed warning that the drug's use can cause a buildup of lactic acid in the blood. In people with chronic hepatitis B infection, the discontinuation of treatment with Atripla—which is not approved for this use—can result in severe flare-ups of hepatitis B infection. Other potential serious side effects reported for the use of Atripla's ingredients include liver toxicity, renal impairment, and severe depression. The most common side effects experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting, and rash.
More than 1 million people are living with HIV and AIDS in the United States today, and 40,000 new cases are reported each year. Now, 28 FDA-approved products in the United States are used to treat HIV infection.
Also, within the last two years, the FDA has approved more than 20 treatments to be used as part of the PEPFAR program, a $15 billion initiative, which President Bush first announced in his 2003 State of the Union Address, to fight the international HIV/AIDS pandemic. PEPFAR is designed to prevent 7 million new HIV infections, treat at least 2 million people infected with HIV, and care for 10 million individuals affected with HIV, orphans with AIDS, and children vulnerable worldwide.
www.fda.gov/cder/drug/infopage/atripla/