GlaxoSmithKline receives CHMP positive opinion for REVOLADE
Published on July 26, 2013 at 9:19 AM
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 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.”
"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.
Ligand Pharmaceuticals Incorporated