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


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Gilead Sciences, Inc. (NASDAQ: 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."

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.


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This is what Nic Chahine averages with his options buys. Not selling covered calls or spreads... BUYING options. Most traders don't even have a winning percentage of 27% buying options. He has an 83% win rate. Here's how he does it.


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Posted In: BiotechNewsFDAGeneralEpclusaEuropean Commission