Gilead receives EU approval for new hepatitis C therapy Epclusa

Gilead Sciences has been received regulatory approval from the European Commission for Epclusa, a new combination therapy for hepatitis C.

Epclusa combines sofosbuvir with velpatasvir and represents the first pan-genotypic, single-tablet regimen for the treatment of adults with chronic hepatitis C viral infections of genotypes 1 to 6.

This also makes it the first single-tablet regimen approved for the treatment of patients with hepatitis C genotypes 2 and 3, without the need to also prescribe ribavirin.

Epclusa becomes Gilead's third sofosbuvir-based treatment to be granted marketing authorisation by the European Commission, with results from four phase III clinical trials involving 1,035 patients supporting the decision.

It was granted an accelerated review procedure by the European Medicines Agency, a status reserved for medicinal products that are expected to be of major public health interest.

Dr John Milligan, president and chief executive officer of Gilead, said: "The European approval of Epclusa reflects our continued focus to bring a cure to all infected patients across the region."