Merck receives FDA Breakthrough Therapy designations for HCV treatment

Merck releases data from multiple HCV phase 2 and 3 studies | Courtesy of
Merck & Co., Inc. said Wednesday it has received two Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the company’s grazoprevir/elbasvir investigational single-tablet regimen to treat chronic hepatitis C virus (HCV) infections.

Merck , commonly called MSD outside the US and Canada, received the designations for the treatment for patients with chronic HCV genotype 4 (GT4) infections and for patients with chronic HCV genotype 1 (GT1) infections with end stage renal disease.

Merck said its representatives will present further information about the broad grazoprevir/elbasvir development program. These presentations, which will include 14 abstracts resulting from the studies, will be given at the International Liver Congress in coming months.

“HCV remains a global public health epidemic,” Merck Research Laboratories Vice President for Infectious Diseases  Eliav Barr said. “At Merck, we are focused on the development of an efficacious, well-tolerated, once-daily therapy that can be used to treat multiple genotypes and a diverse population of chronic HCV patients. Our clinical program is among the largest and most comprehensive, with studies dedicated to patient populations where significant unmet medical need still exists, such as prior treatment failures, as well as those living with co-morbid conditions, including HIV infection, chronic kidney disease and individuals on opiate substitution therapy.”

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