Merck Sharp and Dohme receives EU approval for Zepatier

Merck Sharp and Dohme's new drug Zepatier has been approved for the treatment of chronic hepatitis C viral infections by the European Commission.

The Zepatier regimen, which consists of elbasvir and grazoprevir with or without ribavirin, has been approved in Europe for the treatment of chronic hepatitis C virus in adults with genotype 1 and 4 infections.

In a clinical trial of treatment-naive patients, it was shown that 95 percent of them achieved virologic cure status following 12 weeks of treatment with Zepatier. Approximately 2,000 patients worldwide participated in the clinical development programme for this therapy.

Product launches are estimated to begin between the fourth quarter of 2016 and the first quarter of 2017, with the rollout then continuing across the EU next year.

Dr Mark Toms, medical director for Merck Sharp and Dohme, said: "We are fully committed to providing access to treatment for the greatest number of patients who may benefit from elbasvir/grazoprevir and to helping reduce the disease burden in the UK and worldwide."

Recent study data published in the Annals of Internal Medicine have shown the drug offered a strong performance among patients with chronic hepatitis C of genotypes 1, 4 and 6 who were receiving opioid agonist therapy.

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