First Once-a-Day HIV Pill Approved

PRINCETON, NJ -- The Food and Drug Administration (FDA) today 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.