“A sustained virologic response is the goal for treatment of hepatitis C infection and our clinical study, the largest ever in cirrhotic patients with low platelet counts and chronic hepatitis C infection, demonstrated that eltrombopag in combination with interferon-based therapy, allowed more cirrhotic patients with low platelet counts to reach this goal.” said Dr Rafael Amado Head of Oncology R&D, GlaxoSmithKline.
“We’re looking forward to working with the regulators to attain full marketing authorisation for this indication.” The CHMP opinion is based on review of safety and efficacy data for eltrombopag, including two randomised, double-blind, placebo controlled, multi-centre Phase III studies of more than 1500 patients. A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.
