Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations

Industry News

Pharmaceutical giant Merck, based in Kenilworth, NJ announced that its grazoprevir/elbasvir has received two new Breakthrough Therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.  Grazprevir/elbasvir is an investigational once-daily single tablet combo for the treatment of chronic HCV infection.  Grazoprevir is a protease inhibitor while grazoprevir is a replication complex inhibitor.  The phase II and III clinical data are expected to be presented at The International Liver Congress later this month. HCV infects liver and causes hepatitis C.  According to WHO, 130-150 million people globally have chronic hepatitis C infection and this condition could result in serious, life-long illness.  Current antiviral treatment has only 50-90% success rate and there is an unmet medical need.

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