The Food and Drug Administration (FDA) has announced approval of Atripla Tablets, a fixed-dose combination of three widely-used antiretroviral drugs, in a single tablet taken once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults.
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 and Gilead Sciences 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 holds the rights to efavirenz. 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 (NDA). This would allow the drug to be considered for purchase for use in 15 other countries included under the President's Emergency Plan for AIDS Relief (PEPFAR). HIV-1 affects people worldwide.
Atripla was approved in under three months under FDA's fast track program. The manufacturer plans to make the drug available for purchase in the United States within 96 hours.
"This key breakthrough will help in our battle against HIV/AIDS -- not only in the U.S. but in other countries through the PEPFAR program. I commend those involved for working together to place this lifesaving drug on the fast track so it will be available more quickly to those who need it," said Mike Leavitt, Secretary of Health and Human Services.
The approval of Atripla comes as the result of an expedited review process outlined in a guidance by the FDA in May 2004. With today's approval, FDA will have approved seven co-packaged or fixed-dose combination products since the guidance was issued. For more information about the FDA's Expedited Review Process for HIV/AIDS Drugs, please go to: http://www.fda.gov/oc/initiatives/hiv/.
"Today's approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in the United States and abroad," said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs. "Fixed dose combination products are an important tool in improving the quality of health care in developing nations. The approval of Atripla is a significant step forward in our commitment to providing medical care as effectively and efficiently as possible."
"The approval of Atripla simplifies the treatment regimen for HIV-1 infected adults, and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1. This offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S.," said Dr. Andrew C. von Eschenbach, the Acting Commissioner of Food and Drugs. "Atripla illustrates the outstanding achievements that are attainable when several pharmaceutical companies cooperate with our agency toward a common public health goal. I congratulate the three firms behind this unprecedented success -- and our reviewers, who worked with them every step of the way, on a job extremely well done."
"This new product offers a welcome option for prescribers who follow the recommended initiation of HIV-1 treatment with at least three highly active antiretroviral drugs, a regimen that has the potential to significantly improve the condition of many patients, and help them adhere to their regimen to help minimize the development of viral resistance," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Because all three components of Atripla have been in use for some time, their characteristics and effects are well known."