Gilead Sciences receives new EU approval for HIV therapy Descovy

Gilead Sciences has announced that its new fixed-dose combination HIV therapy Descovy has been approved by the European Commission.

Marketing authorisation has been granted for two doses of Descovy, which consists of emtricitabine and tenofovir alafenamide (TAF). It is the second TAF-based therapy to be ratified for sale in Europe.

Intended for the treatment of adults and adolescents in combination with other HIV antiretroviral agents, the drug showed its effectiveness in a phase III trial of treatment-naive, virologically suppressed, renally impaired and adolescent patients.

It has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth of Gilead's established product Viread, as well as offering improvements in terms of key markers of renal and bone safety.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "We look forward to making Descovy available as quickly as possible throughout the European Union as we continue to advance a pipeline of HIV regimens that contain TAF."

Clinical trial data was reported earlier this month showing the effectiveness of TAF in the treatment of chronic hepatitis B virus infections.