Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline (NYSE: GSK) announced that today, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for GSK’s 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.
“We are very pleased with this latest development as we view Promacta/REVOLADE as an important medicine in this indication, even as the clinical landscape evolves with new potential hepatitis C therapies on the horizon. GSK recently reported increased sales for Promacta in the US, citing growth due to the use in the hepatitis C indication," commented John Higgins, President and Chief Executive Officer of Ligand. “We congratulate our partners at GSK on this achievement and commend GSK’s global Promacta/REVOLADE team on its continued commitment to bring this medicine to patients in need.”
The CHMP opinion is based on review of safety and efficacy data for eltrombopag, including two randomized, double-blind, placebo controlled, multi-center Phase 3 studies of more than 1,500 patients.
A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, but does not always result in marketing authorization.More about thrombocytopenia related to chronic Hepatitis C Infection Hepatitis C virus infection (HCV) is the most common blood borne viral infection, affecting up to 170 million people world-wide. Chronic HCV infection 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 1,2. More about REVOLADE™ (eltrombopag) In the European Union (EU), eltrombopag is currently approved as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia. 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.