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FDA gives Merck Breakthrough Therapy designation to treat chronic hepatitis C virus in dialysis patients
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Merck has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for grazoprevir/elbasvir to treat chronic patients with chronic hepatitis C virus (HCV)genotype 1 (GT1) infection in patients with end-stage renal disease on hemodialysis. The company also received the designation to treat patients with chronic HCV genotype 4 (GT4) infection.
Merck said they will present 14 abstracts from studies evaluating the investigational drug at The International Liver Congress in Vienna, Austria April 22 to 26.
“HCV remains a global public health epidemic," said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. "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.”
Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.