Gilead’s Descovy recommended for EU approval by CHMP

Gilead Sciences' new combination HIV treatment Descovy has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on approving the investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (TAF).

Designed for the treatment of HIV-1 infections in adults and adolescents in combination with other HIV antiretroviral agents, the new therapy option has demonstrated its safety and efficacy in 48-week data from two pivotal phase III trials.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead's established therapy Viread, at less than one-tenth of the dosage strength.

The CHMP’s recommendation will now be reviewed by the European Commission, which will deliver a final verdict on whether or not to approve Descovy in the coming months.

Gilead also had its marketing application for the hepatitis B drug tenofovir alafenamide accepted by the European Medicines Agency earlier this month.