Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US FDA has granted a six-month priority review for Gilead Sciences' once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.
Subscribe to our email newsletter
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.