FTC/TAF dual-nuke approved in the US and Europe
Simon Collins, HIV i-Base
The new dual-NRTI coformulation of emtricitabine (FTC) plus tenofovir alafenamide (TAF) was approved by the FDA and EMA on 4 April and 25 April 2016 respectively.
Although the EU approved two doses of F/TAF: 200/10 mg and 200/25 mg, the US FDA only approved the 200/25 mg formulation.
TAF is a new prodrug of tenofovir which achieves greater intracellular concentrations but with lower plasma drug levels compared to tenofovir disoproxil fumerate (TDF).
The EU indication is for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) and creatinine clearance greater than or equal to 30 mL per minute, in combination with other HIV antiretroviral agents.
Manufactured by Gilead Sciences the brand name is Descovy.
For further details please see the full prescribing information.
- Gilead press statement. U.S. Food and Drug Administration approves Descovy (emtricitabine, tenofovir alafenamide), Gilead’s third TAF-based HIV therapy. (4 April 2016).
- Gilead press statement. European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV. (25 April 2016)