Gilead Sciences Inc. (GILD) Monday said U.S Food and Drug Administration has accepted the supplemental New Drug Application and granted a six-month priority review for once-daily Truvada to reduce the risk of HIV-1 infection among uninfected adults.
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.
The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists.
Truvada is not currently indicated to reduce the risk of HIV infection.
by RTT Staff Writer
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