SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved Merck’s Zepatier (elbasvir and grazoprevir) tablet to treat patients with chronic hepatitis C.The drug had previously received two breakthrough therapy designations from the FDA to treat chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis, as well as for the treatment of chronic HCV GT4 infection
Each tablet contains 50 mg of elbasvir, an NS5A inhibitor and 100 mg of grazopevir, an NS3/4A inhibitor. .
“Continued innovation is needed to help address the worldwide epidemic of chronic hepatitis C virus infection,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “The approval of ZEPATIER is a testament to Merck’s unwavering commitment to improving therapy for patients with hepatitis C virus infection, and we are eager to bring this innovation to patients and physicians in the United States.”