Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Antiviral
Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA)
has voted to support approval of once-daily oral Truvada®
(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of
HIV-1 infection among uninfected adults, an HIV prevention strategy
called pre-exposure prophylaxis or PrEP. If the FDA decides to approve
Truvada for PrEP, it would be the first agent indicated for uninfected
individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3
in favor of approval for Truvada for PrEP in men who have sex with men;
19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners
in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other
individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will
be considered by the FDA as the agency completes its six-month priority
review of Gilead's supplemental New Drug Application (sNDA) of Truvada
for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has
established a target review date under the Prescription Drug User Fee
Act (PDUFA) of June 15, 2012.
The committee's positive recommendation followed presentations today of
efficacy and safety data from several clinical studies of Truvada for
PrEP, including two large placebo-controlled Phase 3 trials sponsored by
the U.S. National Institutes of Health and the University of Washington,
respectively. Several other clinical studies support the use of Truvada
for HIV risk reduction.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1
infection and is currently the most-prescribed antiretroviral treatment
in the United States. Truvada is not indicated for HIV prevention.