FDA grants priority review to Gilead's Truvada for HIV prevention
FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.
Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.
Gilead said that if approved, Truvada would be the first drug indicated for reducing the risk of acquiring HIV. The company's regulatory filing, which it submitted on Dec. 15, is based on results of a study sponsored by the National Institutes of Health and the University of Washington that supported the use of Truvada in reducing the risk of HIV infection.