Gilead Sciences announced that the FDA has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.
The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the U.S. National Institutes of Health and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.
Truvada is a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in adults and pediatric patients 12 years of age and older.
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