FDA designates Merck hepatitis C drug as breakthrough therapy
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.
The agency gave the designation to MK-5172/MK-8742, a combination pill currently in mid-stage clinical development being investigated as a treatment for hepatitis C genotype 1. The FDA gives breakthrough therapy designation to expedite development and review of drugs planned for use in serious or life-threatening conditions when clinical trial evidence indicates it may represent a substantial improvement over existing therapies.
"There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients," Merck Research Labs president Roger Perlmutter said.