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Gilead's HIV drug recommended by CHMP

Gilead's Eviplera has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use as a once-daily, single-tablet regimen for adults with HIV-1

Gilead's Eviplera has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use as a once-daily, single-tablet regimen for adults with HIV-1. Eviplera is a tablet that combines Gilead's Truvada (emtricitabine and tenofovir disoproxil) with Tibotec Pharmaceuticals' Edurant (rilpivirine).

The CHMP, which acts as an advisory board to the European Medicines Agency (EMA), made the recommendation based on data from two phase III trials conducted by Tibotec evaluating the safety and efficacy of rilpivirine compared to HIV treatment efavirenz in patients who had received no previous treatment.

Gilead entered an agreement with Tibotec for the development and commercialisation of the Eviplera single-tablet regimen in July 2009. The product received regulatory approval from the US Food and Drug Administration (FDA) under the name Complera in August 2011.

Dr John C Martin, CEO at Gilead Sciences, said there was a need for the simplification of HIV treatments as patients stay on therapy longer.

He said: "We are pleased to move one step closer to making this potentially important, new simplified treatment option available to physicians and patients in Europe."

The CHMP also recommended Tibotec's Edurant on its own in a separate positive opinion.

26th September 2011

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