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New Drug Application Submitted to FDA for Combination Therapy for Treatment of Genotypes 1, 4, and 6

On May 28, Merck submitted an application to the U.S. Food and Drug Administration (FDA) for a new investigation of grazoprevir/elbasvir, a once per day, single tablet combination treatment for adults infected with chronic hepatitis C (HCV) genotypes 1, 4, or 6. The FDA has 60 days within the date of Merck’s submission to decide if it will review Merck’s application.

This announcement comes after the FDA granted breakthrough therapy status of Merck’s grazoprevir/elbasvir for treatment of chronic HCV adults with end stage renal disease on hemodialysis and adults infected with chronic HCV genotype 4 back in April 2015. At that point, Merck reiterated their plan to focus on the development of the once per a day tablet which would treat multiple genotypes across the HCV patient population and said it was on schedule for submission for FDA approval before the midway point of 2015.

Merck continues to research grazoprevir/elbasvir in multiple HCV genotypes and people with HIV/HCV co-infection, advanced chronic kidney disease, genetic blood disorders, cirrhosis and individuals on opiate substitution therapy.1