Gilead gets EU recommendation for HIV drug regimen

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Gilead Sciences Inc has announced that its three-drug regimen to treat HIV infection has been recommended for approval by a panel of the European Medicines Agency, paving the way for the biotech company to capture more sales in the multibillion-dollar market.

Reuters Health reports that the Committee for Medicinal Products for Human Use (CHMP) backed the treatment, Biktarvy, a once-daily tablet that combines two previously approved drugs – emtricitabine, tenofovir alafenamide and a new integrase inhibitor bictegravir.

The CHMP opinion sets the stage for a likely approval by the European Commission.

The report says the combination, which was approved by the US Food and Drug Administration in February, faced criticism from rival ViiV Healthcare, a joint venture majority-owned by GlaxoSmithKline Plc with Pfizer Inc and Shionogi Ltd.

The joint venture filed a lawsuit soon after the US regulator’s approval alleging that Gilead was infringing patents on ViiV’s dolutegravir, a component of the company’s triple-drug HIV treatment Triumeq.

Reuters Health report

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