EU CHMP recommends approval of Zepatier (grazoprevir/elbasvir) against chronic (long-term) hepatitis C- Merck
The European Medicines Agency (EMA) has recommended the granting of marketing authorisations in the European Union (EU) for the new combination therapy Zepatier (grazoprevir/elbasvir), from Merck, against chronic (long-term) hepatitis C virus (HCV) infection.
The efficacy and safety of Zepatier was evaluated in clinical trials involving approximately 2,000 patients. The medicine also showed a high sustained virologic response (over 90% overall of patients had no detectable virus in their blood 12 weeks after the end of the treatment), and in particular demonstrated its efficacy to treat patients with chronic kidney disease, who have a poor prognosis. The safety profile of the medicine was also considered favourable; the most common side effects reported in clinical trials were fatigue, headache and nausea.
Comment: Zepatier � Merck�s once-daily, fixed-dose combination tablet indicated with or without RBV for the treatment of chronic HCV GT1 or GT4 infection in adults � was approved by the FDA on Jan. 28, 2016, based in part on prior studies from the Phase III program.
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