Gilead has applied to broaden the US label for Descovy (emtricitabine/tenofovir alafenamide) for pre-exposure prophylaxis (PrEP), to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.
The firm has cashed in a coveted Priority Review voucher, yielding an expected review time of just six months.
Descovy is approved in combination with other antiretroviral agents for the treatment of HIV, but is not indicated for PrEP.
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