Merck & Co’s single-pill hepatitis C regimen grazoprevir/elbasvir has received two breakthrough designations from the US Food and Drug Administration.
The announcement comes just a couple of months after the FDA revoked the combo’s breakthrough status for HCV genotype 1, due to the highly-effective drugs from Gilead Sciences and AbbVie that are already on the market – Sovaldi (sofosbuvir), Harvoni (sofosbuvir/ledipasvir) and Viekira Pak (ombitasvir/paritaprevir/dasabuvir).
However, the FDA has now issued new breakthrough designations for patients with chronic HCV genotype 4 and those with genotype 1 infection in patients with end-stage renal disease on haemodialysis.
Merck will report a range of mid- and late-stage clinical data for grazoprevir/elbasvir at the International Liver Congress in Vienna later this month. Some 14 abstracts are scheduled to be presented from trials in a wide range of HCV patients, including those with chronic kidney disease, HIV co-infection, cirrhosis, and prior treatment failures.
The company added that it remains on track to file the combo in the USA before the summer.