EMA Advisory Committee Recommends Gilead’s HIV Combo Drug
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion for Gilead Sciences’ marketing authorization application (MAA) for Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg; R/F/TAF), an investigational single tablet regimen for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine, and with a viral load less than 100,000 copies per mL. Odefsey combines Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, owned by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and marketed by Janssen Cilag International NV.
TAF is a 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).
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.
Source: Gilead Sciences