Fixed-dose combination of rilpivirine/tenofovir/FTC (Eviplera) recommended for approval in Europe
On 23 September 2011 the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, adopted a positive opinion on the Marketing Authorisation Application for the once-daily single-tablet fixed dose combination of the NNRTI (rilpivirine) with Truvada (emtricitabine and tenofovir).
The fixed dose combination will be called Eviplera in Europe.
It is notable that the indication is restricted to treatment of HIV-1 infection in antiretroviral-naive adults with a viral load less than 100,000 HIV-1 RNA copies/mL.
In the US, where the fixed dose combination is already approved and marketed as Complera, the indication indication only included a caution against using in patients with baseline viral load >100,000 copies/mL.
The CHMPs positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). Gilead expects the European Commission to issue its decision on the marketing authorisation for the Eviplera single-tablet regimen later this year.
Source: Gilead press release. European CHMP adopts positive opinion for Eviplera, a once-daily single-tablet regimen for the treatment of HIV infection. (23 Septemebr 2011).