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Lifestyle Health and Wellbeing 30 Apr 2018 Gilead's three-drug ...

Gilead's three-drug HIV regimen wins European panel approval

REUTERS
Published Apr 30, 2018, 9:57 am IST
Updated Apr 30, 2018, 9:57 am IST
Biktarvy is once-daily tablet combining emtricitabine, tenofovir alafenamide and integrase inhibitor bictegravir.
The combination, which was approved by the U.S. Food and Drug Administration in February, faced criticism from rival ViiV Healthcare. (Photo: Pixabay)
 The combination, which was approved by the U.S. Food and Drug Administration in February, faced criticism from rival ViiV Healthcare. (Photo: Pixabay)

Gilead Sciences Inc said on Friday its three-drug regimen to treat HIV infection was 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.

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 combination, which was approved by the U.S. 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 U.S. regulator’s approval alleging that Gilead was infringing patents on ViiV’s dolutegravir, a component of the company’s triple-drug HIV treatment Triumeq.

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