GSK wins priority review for new Promacta indication
This article was originally published in Scrip
Executive Summary
The US FDA has awarded GlaxoSmithKline priority review for its supplemental new drug application for Promacta (eltrombopag; marketed in Europe as Revolade) used to treat thrombocytopenia in adults with hepatitis C virus. The drug is already available in the US to treat thrombocytopenia in patients with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.