On April 7, Merck & Co. announced the Food & Drug Administration (FDA) granted breakthrough therapy status for a once per a day tablet combining the NS3/4A protease inhibitor grazoprevir and the NS5A inhibitor elbasvir for the Hepatitis C Virus (HCV). The tablet is specifically for patients with HCV genotype 4 and patients with HCV genotype 1 in end-stage renal disease on haemodialysis.
This announcement comes after the FDA withdrew status for a combination treatment for patients with HCV genotype 1 in early 2015 citing “the availability of other recently approved treatments for genotype 1 patients.”
Merck & Co has reiterated their plan to focus on the development of the once per a day tablet which will treat multiple genotypes across the HCV patient population and said it’s on schedule for submission for FDA approval before the midway point of 2015.
Analysis from the progress of grazoprevir and elbasrvir will be presented at the International Liver Congress later in April.1
Barber, J. Merck & Co’s hepatitis C combination grazoprevir, elbasvir gains FDA breakthrough therapy status. FirstWord Pharma: 2015.