CHMP Adopts Positive Opinion On Gilead Type II Variation Application For Truvada

(RTTNews) - Gilead Sciences, Inc. (GILD) announced that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company's Type II variation application for once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP.

Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.

The Type II variation application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. In studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss.The incidence and types of side effects were consistent with Truvada's safety and tolerability profile when used as part of an HIV treatment regimen.

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.