If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV, the company said.
The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the US National Institutes of Health and the University of Washington.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is the prescribed antiretroviral treatment in the US.
Truvada is not currently indicated to reduce the risk of HIV infection.