CHMP recommends Descovy (emtricitabine and tenofovir alafenamide) to treat HIV-1 infection-- Gilead Sciences

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for two doses of Descovy (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.