EMA Accepts Merck’s MMA for Hepatitis C Combo Drug

The European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for Merck & Co. Inc.’s grazoprevir/elbasvir (100 mg/50 mg), an investigational, once-daily, single-tablet combination therapy for treating adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.1 The EMA will initiate review of the MAA under accelerated assessment timelines.

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 company submitted a new drug application for grazoprevir/elbasvir (100 mg/50 mg) to the US Food and Drug Administration (FDA) in May 2015 for treating 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 FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for treating patients with chronic HCV GT1 with end-stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for treating 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.

Grazoprevir/elbasvir is Merck's investigational, once-daily, single-tablet combination therapy consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck's broad clinical trials program, grazoprevir/elbasvir is being evaluated in multiple HCV genotypes, including patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis, and in those on opiate substitution therapy.

Source: Merck & Co.

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