FIRST ONCE-A-DAY COMBO HIV/AIDS DRUG RECEIVES FDA APPROVAL

The FDA has approved Atripla, the first single-dose, once-a-day combined drug tablet to treat HIV/AIDS, the agency said.

Atripla (efavirenz/emtricitabine/tenovir disoproxil fumarate), indicated for the treatment of HIV-1 in adult patients, was approved in less than three months under the FDA's fast-track approval program. The drug is the product of the first joint venture between two U.S. companies to develop and commercialize an HIV/AIDS drug.

Acting FDA Commissioner Andrew von Eschenbach called the new drug a "landmark in the treatment of HIV/AIDS," and said the collaboration was a "paradigm for separate companies to come together to create single solutions to health problems."

Atripla -- a fixed-dose combination of three HIV/AIDS drugs already on the market -- was produced by Bristol-Myers Squibb (BMS) and Gilead. The drug is made up of BMS' drug Sustiva and Gilead's Viread and Emtriva. Merck, which own the rights to Sustiva in some areas, is collaborating with the other two drugmakers to make the product available, the FDA said.

Atripla can be taken alone or in combination with other antiretroviral drugs and will be available in the U.S within seven business days, the companies said.

The drug will be available for purchase and use in 15 other countries through the President's Emergency Plan for Aids Relief. Murray Lumpkin, the FDA's deputy commissioner for international and special programs, said the one-pill, once-a-day regimen will meet the "medical and logistical needs" of people who live in developing economies, who may find it hard to take a large number of pills over a 24-hour period.