Gilead Gets European Commission Marketing Authorization for Its Epclusa For Chronic Hepatitis C Treatment

Gilead Sciences, Inc. GILD revealed that the European Commission has accorded marketing authorization for its Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults, who are suffering from genotype 1-6 chronic hepatitis C virus (HCV) infection.

Gilead said that the combination of sofosbuvir and velpatasvir for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).

The drug maker said that SOF/VEL was the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the RBV requirement. The company added that physicians have the options to consider the inclusion of RBV for genotype 3 infected patients with compensated cirrhosis.

Gilead's president and CEO, John Milligan, said, "The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected. The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible."

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The company stated that the Marketing Authorization followed an accelerated review procedure by the EMA, reserved for medicinal products expected to be of major public health interest. As a result, it enabled the marketing of SOF/VEL in all 28 countries of the European Union.

Currently, close to one million patients were prescribed a sofosbuvir-based regimen throughout the world.

At time of writing, Gilead was up 0.60 percent at $85.99.