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Gilead Gets European CHMP's Positive Opinion On Its Type II Variation Application For Truvada

R. Chandrasekaran

Gilead Sciences, Inc. (NASDAQ: GILD) revealed Friday that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA)'s scientific committee, has adopted a positive opinion on its Type II variation application for once-daily Truvada. According to the company, the drug should be taken (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to cut down the risk of sexually acquired HIV-1 infection.

Gilead said Truvada was given approval by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The drug is the most prescribed antiretroviral medicine currently in Europe as part of combination therapy. The company said that the CHMP's recommendation would be reviewed by the European Commission to approve medicines for use in the 28 countries of the region.

According to Professor Jean-Michel Molina, Hôpital Saint Louis in Paris and University of Paris: "Evidence supports pre-exposure prophylaxis, in combination with safer sex practices, to reduce the risk of sexually acquired HIV and we look forward to the potential public health impact of PrEP, in addition to increasing access to testing and universal treatment of people living with the disease, in helping to lower HIV transmission rates in Europe."

The company said the Type II variation application was based on the two large placebo-controlled studies results of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the National Institutes of Health and the University of Washington, respectively. The company added that during the trials of Truvada for PrEP, the most commonly indicated side effects witnessed were headache, stomach discomfort and weight loss.

Gilead indicated the incidence and types of side effects were in line with Truvada's safety and tolerability profile when used as part of an HIV treatment regimen.

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