EU CHMP recommends approval of Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) for HIV/AIDS- Gilead Sciences

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide), from Gilead Sciences, for the treatment of adults and adolescents infected with human immunodeficiency virus 1 (HIV 1).

Comment: TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead�s Viread (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.