Merck Sharpe and Dohme granted CHMP recommendation for Victrelis

Merck Sharpe and Dohme has won a recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its new hepatitis C treatment Victrelis.

The investigational protease inhibitor has been endorsed for approval by the European Commission (EC) for use in combination with peginterferon alfa and ribavirin among adults with compensated liver disease who have proven unresponsive to therapy.

This recommendation was based on results from two large-scale phase III clinical trials involving around 1,500 patients, during which the drug showed its safety and efficacy.

Following this decision, the EC will assess Victrelis for marketing authorisation approval in the 27 countries of the EU.

Dr Peter Kim, president of Merck Research Laboratories, said: "Victrelis would represent the first in a new class of medicines known as HCV protease inhibitors granted marketing authorisation in the European Union."

Earlier this month, the company was granted approval from the UK's National Institute for Health and Clinical Excellence for Simponi, its treatment for rheumatoid arthritis and other musculoskeletal disorders.