EMA Recommends New Use for Gilead Antiviral Drug
Gilead Sciences has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), on its application for Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg) as a prevention tool for human immunodeficiency virus-1 (HIV-1). Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for HIV-1. Truvada had 2015 global sales of $3.5 billion.
The CHMP's recommendation will next 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