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Home Industry News Gilead’s Vosevi recommended by CHMP for EU hepatitis C approval

Gilead’s Vosevi recommended by CHMP for EU hepatitis C approval

10th July 2017

Gilead Sciences' new hepatitis C therapy Vosevi has been recommended by European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the approval of the investigational combination therapy as a treatment for all chronic hepatitis C genotypes.

Vosevi is a once-daily single-tablet regimen of sofosbuvir, velpatasvir and voxilaprevir, and is intended for use in patients with and without compensated cirrhosis affected by genotypes 1 to 6 of the virus, regardless of their prior therapy history.

This decision from the CHMP is supported by data from four phase III studies, which have shown the effectiveness of the drug both among treatment-naive patients and those who have failed to respond to other therapies.

It follows an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest, with a final regulatory decision to be issued by the European Commission in the coming weeks.

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