U.S. approves Glaxo, Gilead AIDS drug combinations
Last Updated: 2004-08-02
WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Monday said it has approved two once-daily antiretroviral drug combinations made by Glaxosmithkline Plc and by Gilead Sciences Inc. for use in the United States and in developing countries.
Truvada, the Gilead drug, contains emtricitabine and tenofovir.
EPZICOM, the Glaxo drug, contains lamivudine and abacavir.
The fixed-dose combinations are designed to simplify treatment regimens.
Proponents of aggressively treating AIDS around the world consider the combinations vital to fighting the disease in Africa and the Caribbean.
The Bush administration had resisted spending U.S. money on HIV-fighting drug combinations, arguing they had not been proven safe and effective.
Under pressure from AIDS activists and some lawmakers, health officials set up an approval process to certify that the combination drugs met U.S. standards.
HIV, which causes AIDS, has infected 43 million people worldwide and has killed more than 25 million. There is no cure, but combination drug treatments can control the virus and keep patients relatively healthy.