Grazoprevir/Elbasvir, Merck’s investigational chronic hepatitis C therapy, granted FDA Breakthrough Therapy designations
Posted: 9 April 2015 |
Merck has announced that grazoprevir/elbasvir has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA)…
Merck has announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA).
The Breakthrough Therapy designations are for the treatment of patients with chronic HCV genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.
Presentations of studies evaluating grazoprevir/elbasvir to be presented at the International Liver Congress
Additionally, the company announced presentations from the broad grazoprevir/elbasvir development program at the upcoming International Liver Congress™, April 22 – 26 2015. A total of 14 abstracts from studies evaluating grazoprevir/elbasvir are scheduled to be presented, including three from the company’s ongoing Phase 3 pivotal C-EDGE program, one from the pivotal Phase 2b/3 C-SURFERstudy, and seven from ongoing or completed Phase 2 studies.
“HCV remains a global public health epidemic. 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,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “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.”
In October 2013, the FDA granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with chronic HCV genotype 1 (GT1). In January 2015, the FDA notified Merck of its intention to rescind that Breakthrough Therapy designation. The FDA has now granted two new Breakthrough Therapy designations for grazoprevir/elbasvir; the designations are now for the treatment of patients infected with chronic hepatitis C virus GT1 with end stage renal disease on hemodialysis, and patients infected with chronic HCV genotype 4 (GT4).
For more information about Merck, please visit www.merck.com.
