Merck Sharp and Dohme’s new hepatitis therapy accepted for EU review

Merck Sharp and Dohme has announced that its new combination therapy for chronic hepatitis C infections has been accepted for review by the European Medicines Agency.

The regulator has accepted a marketing authorisation application for grazoprevir/elbasvir, an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes 1, 3, 4 or 6 infections.

An accelerated assessment timeline has been assigned to the drug due to the strong potential it holds to address a currently unmet medical need.

The application is supported by positive safety and efficacy data from the  C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT studies.

Dr Roy Baynes, senior vice-president of clinical development at Merck Research Laboratories, said: "We are pleased to be working with regulatory authorities as we advance grazoprevir/elbasvir for appropriate patients living with chronic hepatitis C around the world."

This comes after the company's new melanoma therapy Keytruda was approved by the European Commission last week.