Priority Review Granted for Promacta for Thrombocytopenia in Chronic Hepatitis C
Ligand Pharmaceuticals announced that its partner GlaxoSmithKline has been granted priority review from the FDA for its supplemental new drug application (sNDA) for Promacta (eltrombopag) to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection.
A Priority Review designation is given to drugs that if approved, offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under the Prescription Drugs User Fee Act, the goal for completing a Priority Review is six months.
Promacta is a thrombopoietin receptor agonist approved as a treatment for thrombocytopenia due to chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adults who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.