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23 January 2017Big Pharma

EMA to review Gilead application for hepatitis C drugs

Gilead’s marketing authorisation application for sofosbuvir 400mg, velpatasvir 100mg and voxilaprevir 100mg—treatments for chronic hepatitis C virus (HCV)—is under assessment by the European Medicines Agency (EMA).

Norbert Bischofberger, executive vice president of research and development at Gilead, said: “Direct-acting antiviral treatments have transformed our ability to treat hepatitis C.

“However, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed.”

He added: “The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”

The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest.

Gilead has also submitted a New Drug Application to the US Food and Drug Administration for sofosbuvir, velpatasvir and voxilaprevir, in December 2016.

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