FRIDAY, SEPTEMBER 30, 2016

GSK receives positive opinion on chronic hepatitis C treatment

GlaxoSmithKline, a research-based pharmaceutical company, announced on Friday that it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for REVOLADE, a hepatitis C treatment.

REVOLADE, also known as eltrombopag, is a treatment for thrombocytopenia, also known as low platelet counts, in adult patients with chronic hepatitis C infection where the degree of thrombocytopenia is the main factor that prevents the ability to maintain optimal interferon-based therapy.

The CHMP opinion is based on a review of efficacy and safety data for eltrombopag, including two placebo-controlled, double-blind, randomized, multi-center Phase III studies involving more than 1,500 patients.

"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." Rafael Amado, the head of oncology research and development at GSK, said. "We're looking forward to working with the regulators to attain full marketing authorization for this indication."

Receiving a CHMP positive opinion is one of the last steps before marketing authorization is allowed by the European Commission. A positive CHMP opinion does not always result in marketing authorization.

Treatment with pegylated interferon and ribavirin is the current standard of care for patients with hepatitis C virus. The American Association for the Study of Liver Diseases currently reports the presence of thrombocytopenia among the relative contraindications to antiviral therapy.