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Gilead submits sNDA for Descovy
FOSTER CITY, Calif.—Gilead Sciences, Inc. announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (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 3 DISCOVER trial, which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men who are 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.
Results from the DISCOVER trial, which were 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. And statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy, versus those receiving Truvada.
Among DISCOVER trial participants, Descovy and Truvada were well tolerated and had low discontinuation rates due to adverse events of 1.3 percent and 1.8 percent, respectively. The most common (≥5 percent in the Descovy group) drug-related adverse event was diarrhea.
“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, M.D., 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.”
In the U.S., Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥25 kg. It is not indicated for PrEP. Truvada is indicated, in combination with safer sex practices, for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative and weigh ≥35 kg. Descovy and Truvada each have a boxed warning in their respective product labels, regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a boxed warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection.
“Studies, including DISCOVER, have shown that adherence to a once-daily PrEP regimen can decrease the risk of HIV acquisition. If approved, Descovy may help equip health care providers with an additional preventive option thereby potentially expanding the impact of PrEP,” added Edwin DeJesus, M.D., FACP, FIDSA, Medical Director, Orlando Immunology Center.