EU adopts positive opinion on dual formulation of F/TAF

22 March 2016. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 26 February 2016, Gilead Sciences issued a press release reporting that the scientific committee of the European Medicines Agency (EMA) had adopted a positive opinion for the new dual NRTI combination of emtricitabine (FTC) plus tenofovir alafenamide (TAF).

A positive opinion is usually sufficient for a drug to be approved by the European Commission, with the final decision expect by the third quarter of 2016.

The formulation uses 200 mg of FTC with two doses available for TAF: 25 mg and 10 mg.

Despite the Gilead press release, this is not a fixed dose combination because F/TAF needs to be taken in combination with other additional drugs.

F/TAF is manufactured by Gilead and will have the tradename Descovy.

Reference:

Gilead PR. European CHMP adopts positive opinion for Gilead’s fixed-dose combination Descovy (emtricitabine/tenofovir alafenamide) for the treatment of HIV (26 February 2016).
http://www.gilead.com/news/press-releases/2016/2/european-chmp-adopts-positive-opinion-for-gileads-fixeddose-combination-descovy-emtricitabinetenofovir-alafenamide-for-the-treatment-of-hiv