Gilead Sciences submits sBLA for Descovy for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection

Gilead Sciences, Inc.announced that the company has submitted a supplemental New Drug Application (sNDA) to the FDA for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) 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. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.

The filing is based on the results of the Phase III DISCOVER trial which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men at high-risk for sexually acquired HIV infection. Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) for PrEP is currently the only FDA approved product indicated to reduce the risk of sexually acquired HIV-1 in individuals ( greater than 35 kg) who are HIV-negative and at risk for HIV.

Results from the DISCOVER trial, presented at the 2019 Conference on Retroviruses and Opportunistic Infections, demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition. Additionally, statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy versus those receiving Truvada.