The US Food and Drug Administration (FDA) has granted approval to United States-based Gilead Sciences for HIV pre-exposure prophylaxis indication of Descovy (emtricitabine 200mg and tenofovir alafenamide 2 mg tablets; F/TAF), it was reported on Friday.

The product is intended to decrease the risk of sexually acquired HIV-1 infection in adults and adolescents weighing minimum 35kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.

According to a priority review designation, the US FDA has approved the supplemental new drug application (sNDA) for Descovy. The approval was based on data from the DISCOVER multi-year global phase three registrational clinical study. The trial evaluated the safety and efficacy of Descovy for PrEP compared against Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg tablets; F/TDF) for PrEP in decreasing the risk of acquiring HIV-1 infection. The DISCOVER trial showed that Descovy achieved non-inferiority to Truvada in study participants who were at risk of HIV acquisition, said the company. The company stated that Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.