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Merck’s grazoprevir/elbasvir therapy receives FDA designations

Originally posted on: Vaccine News Daily Reports

Merck Research Laboratories’ grazoprevir/elbasvir therapy has received two new Breakthrough Therapy designations from the Food and Drug Administration, reflecting encouraging news for patients with Hepatitis C virus (HCV), chronic kidney disease, cirrhosis or HIV co-infection.

Merck will present the latest data from its Phase 2 and 3 studies testing grazoprevir/elbasvir, the company’s investigational chronic HCV therapy, which is specifically for patients with chronic HCV genotype 1 (GT1) as well as end-stage renal disease, and for patients with chronic HCV genotype 3 (GT4) infections.

Merck has also announced that 14 abstracts of various studies pertaining to grazoprevir/elbasvir will be presented at the International Liver Congress April 22-26 in Vienna, Austria. Three of the abstracts will be Merck’s ongoing Phase 3 pivotal C-EDGE program; one will discuss the pivotal Phase 2b/3 C-SURGER study; and seven will be taken from either complete or ongoing Phase 2 studies.

“HCV remains a global public health epidemic,” Merck vice president for infectious disease research 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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