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news.Gilead Sciences has submitted a supplemental New Drug Application (sNDA) to the US FDA for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP), indicated for reducing risk of HIV-1 infection in uninfected adults.
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According to the company, Truvada once approved would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP.
The sNDA is backed by data from two large placebo-controlled trials of Truvada as PrEP, sponsored by the US National Institutes of Health (NIH) and the University of Washington.
Gilead Sciences chairman and CEO John C Martin said the results from the clinical trials indicate that Truvada may cater to public health need to reduce new HIV infections.
"Gilead is proud to have played a part in helping to define the use of Truvada as a potential new prevention tool and we commend the many institutions, investigators and study volunteers for their commitment to advancing this important area of research," Martin added.