Gilead Sciences’ new hepatitis C therapy accepted for EU review

Gilead Sciences has announced that its new combination hepatitis C therapy has been accepted for review by the European Medicines Agency.

The regulator has accepted the company's marketing authorisation application for an investigational, once-daily, single tablet regimen of sofosbuvir, velpatasvir and voxilaprevir for the treatment of chronic hepatitis C virus-infected patients.

Data from two phase III studies, POLARIS-1 and POLARIS-4, have been submitted to support the application. These trials evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral-experienced patients with hepatitis C genotypes 1-6.

It was shown that 97 percent of patients treated with Gilead's therapy achieved the primary efficacy endpoint in terms of response rates.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer 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."

This comes after another Gilead therapy, Vemlidy, was approved in Europe for the treatment of chronic hepatitis B virus infections in adults and adolescents earlier this month.

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