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CHMP to review MAA of elbasvir/grazoprevir for HCV
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Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency will be reviewing its marketing authorization application for elbasvir/grazoprevir, a treatment regimen for hepatitis C virus infection, on a standard timetable rather than an accelerated assessment.
The application includes an authorization request to market elbasvir/grazoprevir (Merck) at 50 mg and 100 mg for the treatment of HCV in adults.
“We are excited about the potential of elbasvir/grazoprevir and look forward to continuing our discussions with the European Medicines Agency to bring this important medicine to appropriate patients with chronic hepatitis C in the European Union,” Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories, said in the press release.
An integrated analysis presented at The Liver Meeting 2015 by Co-Chief medical editor for HCV Next, Ira M. Jacobson, MD, of the department of Medicine at Mt. Sinai Beth Israel Medical Center, New York, showed that this combination was safe and effective for both treatment-experienced and naive patients with HCV and compensated cirrhosis.
Disclosure: Baynes is employed by Merck.