Gilead's three-drug HIV regimen wins European panel approval
Biktarvy is once-daily tablet combining emtricitabine, tenofovir alafenamide and integrase inhibitor bictegravir.
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.