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 PrEP to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.
Gilead has also submitted a priority review voucher, along with the sNDA, for provision of review time of six months.
The company has submitted sNDA based on the results of the phase 3 Discover trial that assessed 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 said to be 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.
According to the company, the Discover trial results has showed that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition.
Gilead has also observed statistically significant improvements in renal and bone laboratory parameters in the participants receiving Descovy against the patients securing Truvada.
Descovy, in combination with other antiretroviral agents, is approved in the US to treat HIV infection in patients weighing ≥25 kg and is not indicated for PrEP.
Gilead Sciences research and development head and chief scientific officer Dr John McHutchison said: “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.”