European regulators have agreed to review MSD’s investigational hepatitis C therapy grazoprevir/elbasvir under an accelerated assessment process.
The once-daily, single-pill combination therapy is being developed for the treatment of adult patients with chronic hepatitis C (HCV) genotypes 1, 3, 4 or 6.
The speedy review signals that regulators believe the therapy could potentially offer a significant improvement over current treatment options for HCV infection.
The drug’s file includes data from the pivotal C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, assessing the combo, with or without ribavirin, in HCV patients with various genotypes.
US regulators are also currently reviewing the therapy as a treatment for chronic HCV genotypes 1, 4 or 6 , where it also carries Breakthrough status for patients with genotype 4 and those with genotype 1 who have end stage renal disease and are on haemodialysis.