Gilead submits supplemental NDA for once-daily Descovy for HIV PrEP

Gilead Sciences announced that the company has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for Descovy for pre-exposure prophylaxis 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 at high-risk for sexually acquired HIV infection. Truvada for PrEP is currently the only FDA approved product indicated to reduce the risk of sexually acquired HIV-1 in individuals who are HIV-negative and at risk for HIV. Results from the DISCOVER trial 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. In the United States, Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing greater than or equal to25 kg and 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 greater than or equal to35 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. 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 drug-related adverse event was diarrhea. The use of Descovy for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.
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