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news.Merck, known as MSD outside the US and Canada, announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), 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.
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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.
The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic HCV infection.
Collectively, these trials evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (i.e., HIV co-infection, chronic kidney disease stages 4 and 5).
The company submitted a New Drug Application for grazoprevir/elbasvir (100mg/50mg) to the U.S. Food and Drug Administration (FDA) in May 2015 for the treatment of chronic HCV GT1, 4 or 6 infection, and is submitting additional license applications in other markets by the end of 2015.
In April 2015, the U.S. FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4.
Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.