Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100 mg/50 mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection. The EMA will initiate review of the MAA under accelerated assessment timelines.

“Given the diversity of patient populations affected by chronic hepatitis C, including the estimated 15 million people living with the disease in Europe, it is important to provide patients and physicians with treatment options,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “We are pleased to be working with regulatory authorities as we advance grazoprevir/elbasvir for appropriate patients living with chronic hepatitis C around the world.”

The EMA’s accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest, such as the treatment of chronic HCV infection. The Committee for Medicinal Products for Human Use (CHMP) will continue to evaluate the accelerated assessment status throughout the MAA evaluation process.

For more details, go to: http://www.mercknewsroom.com/news-release/hepatitis-c-newsroom/merck-announces-european-medicines-agency-acceptance-marketing-aut