Gilead Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Once-Daily Descovy

Gilead Sciences (NASDAQ:GILD) has announced it has submitted a supplemental new drug application (NDA) to the US Food and Drug Administration (FDA) For Descovy for pre-exposure prophylaxis (PrEP) to reduce the chances of acquired HIV-1 infection among people who are HIV-negative and risk getting HIV.

As quoted in the press release:

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 3 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 (≥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.

“Data have shown that when used in combination with other agents for HIV treatment, Descovy offers high efficacy and additional benefits with respect to renal and bone safety compared with Truvada. Now, the results from the DISCOVER trial suggest that Descovy may offer those same benefits for HIV prevention, which are important considerations for the potential long-term use of PrEP,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We look forward to working with the FDA to help evaluate bringing this option to people at risk of acquiring HIV infection.”

Click here to read the full press release.