Merck (MSD) has recently announced that grazoprevir/elbasvir, which is a single tablet investigational regimen to treat chronic hepatitis C virus (HCV) infection, has received two Breakthrough Therapy designations granted by the United Stated Food and Drug Administration (FDA) to address treatment of those suffering from chronic HCV genotype 4 (GT4) infection, and with chronic HCV genotype 1 (GT1) infection in individuals with end stage renal disease currently on hemodialysis.
The company will present at the International Liver Congress™ on the grazoprevir/elbasvir development program. 14 abstracts will be presented concerning the evaluation of grazoprevir/elbasvir, including 3 abstracts from the ongoing Phase 3 C-EDGE program, 1 from the Phase 2b/3 C-SURFER study, and 7 from other completed and ongoing Phase 2 studies. The data presented emphasizes the company’s commitment to advancing a broad acting oral regimen. The International Liver Congress™ 2015 – the 50th annual congress of the European Association for the Study of the Liver will he held at the Reed Messe Convention Center in Vienna, Austria between April 22 and April 26, 2015.
Eliav Barr from Merck Research Laboratories said in a press release: “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. 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.”
The FDA granted Breakthrough Therapy designation in October 2013 for grazoprevir/elbasvir with the purpose of treating patients with chronic HCV genotype 1 (GT1). In January 2015, Merck was notified of the FDA’s intention of rescinding that Breakthrough Therapy designation. The FDA granted two new Breakthrough Therapy designations to treat patients infected with chronic HCV genotype 4 (GT4) and those infected with chronic HCV GT1 with end stage renal disease on hemodialysis with grazoprevir/elbasvir. This designation is intended to accelerate the advancement and review of a candidate to treat life-threatening diseases.