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European Commission approves Zepatier for chronic hepatitis C infection

pharmafile | August 1, 2016 | News story | Research and Development, Sales and Marketing  

MSD, known as Merck in the US and Canada, has announced that the European Commission has approved Zepatier (elbasvir/grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus genotype (GT) 1 or GT4.

The clinical trial program for Zepatier included thousands of participants worldwide, and included patients with known treatment challenges, such as compensated cirrhosis and for those in whom treatment with peginterferon plus ribarivin has not worked. In late-stage trials, Zepatier proved efficacious when compared with Gilead’s blockbuster Sovaldi.

Chronic hepatitis C affects 15 million people in Europe, alone, with GT1 the most common form accounting for 66% of cases. This drug has been indicated as a 12-week, once-daily regimen. The product is expected to launch in the EU between Q4 2016 and Q1 2017.

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Dr Roger Perlmutter, president at Merck Research Laboratories, says: “The approval of Zepatier, following approvals in the US and Canada earlier this year, is an important step in offering a new and effective treatment for millions of people infected with hepatitis C virus GT1 or GT4.”

Professor Rafael Esteban, professor of medicine at the Universidad Autonoma de Barcelona, comments: “In clinical trials, Zepatier achieved high cure rates among a broad range of chronic hepatitis C patients with GT1 or GT4 infection, from patients who are treatment-naïve to many of those whose chronic HCV infection has been historically difficult-to-treat, providing an important new option in the fight against this global public health epidemic.”

Sean Murray

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