EMA Delays Marketing Decision on Merck Hep C Pill

Merck’s marketing authorization application for its chronic hepatitis C combo pill elbasvir/grazoprevir to the European Medicines Agency will be reviewed sometime next year on a standard timeline, not an accelerated process as previously announced.

The EMA’s Committee for Medicinal Products for Human Use informed Merck that a decision on the application is expected in mid-2016.

In April, Merck announced that elbasvir/grazoprevir had picked up two breakthrough designations from the FDA, covering genotype 1 hepatitis patients who have reached end-stage kidney failure, as well as genotype 4. That news came months after the FDA threatened to rescind a breakthrough designation, citing the recent approvals of drugs to treat genotype 1 hepatitis C.