GSK gets positive CHMP opinion for Revoladein for thrombocytopenia associated with chronic hepatitis C infection

London, UK
Monday, July 29, 2013, 17:15 Hrs  [IST]

GlaxoSmithKline (GSK) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Revolade(eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

“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.
Hepatitis C virus (HCV) infection is the most common blood borne viral infection, and is associated with chronic liver disease which can lead to a number of blood-related disorders including low platelet count (thrombocytopenia). Treatment with pegylated interferon and ribavirin is the current standard of care for patients with HCV, however both the European Association for the Study of the Liver guidelines and the American Association for the Study of Liver Diseases report the presence of thrombocytopenia among the relative contraindications to antiviral therapy.

In the European Union (EU), eltrombopag is currently approved as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP). In the US, eltrombopag is marketed under the trade name PROMACTA and is currently approved as a treatment for patients with chronic immune (idiopathic) thrombocytopenia who have had insufficient response to corticosteroids, immunoglobulins, or splenectomy and as a treatment for thrombocytopenia in patients with chronic hepatitis C infection to allow the initiation and maintenance of interferon-based therapy.

The most important serious adverse reactions identified in the ITP or HCV trials were hepatotoxicity, including hepatic decompensation events and thrombotic/ thromboembolic events.

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