Today, Merck announced that its hepatitis C drugs have been designated breakthrough therapies by the US Food and Drug Administration (FDA).
The news comes three months after the agency said that it would rescind breakthrough designation, due to the evolving hepatitis C treatment landscape and the introduction of competing drugs for the disease. Since January, the FDA has reversed its decision, in part, providing Merck with two new Breakthrough Therapy designation titles in narrow patient subpopulations to replace the broader one it lost.
In 2013, the agency granted breakthrough status to grazoprevir/elbasvir combo for their use in patients with hepatitis C genotype 1. In January, the FDA took back the designation. Now, Merck said that it has received two new Breakthrough therapy designations from the FDA for the treatment of patients with chronic hepatitis C virus (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.
In mid-stage studies, the grazoprevir/elbasvir combo cured at least 90 percent of infected patients. Merck is now testing the combo in late-stage studies. Breakthrough Therapy designation is intended to expedite development and review timelines.
Even with a shorter timeline, Merck’s combo is a late arrival in the new hepatitis C market. Analysts estimate Gilead Sciences brought in at least $12 billion in combined sales of Sovaldi and Harvoni in 2014, and AbbVie also introduced Viekira Pak.
“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.”
Merck said that it will present various study data on the drug candidate at the 2015 meeting of The International Liver Congress in Vienna, Austria, taking place the week of April 22.
Last updated: 4/8/15; 11:05am EST