GSK files NDA with FDA for promacta/revolade

WASHINGTON GlaxoSmithKline has filed a new drug application with the Food and Drug Administration to market the drug promacta/revolade for the treatment of chronic idiopathic thrombocytopenic purpura, a disease characterized by low blood platelet counts. The drug application was submitted based on a Phase II and III trial.

Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding. The drug, also known as eltrombopag, is an oral drug that causes the cells in bone marrow to produce platelets.

“Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor,” said Paolo Paoletti, M.D., senior vice president of the Oncology Medicine Development Center at GSK. “GSK is pleased with the data provided to support the NDA and hopeful that, if approved, promacta/revolade may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease.”