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FDA Grants Priority Review for Promacta for Treatment of Thrombocytopenia in Adults With Chronic HCV
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 6 months.
Eltrombopag, known as Promacta in the U.S. and as Revolade in Europe, is currently approved in 89 countries around the world for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia.
Promacta may cause hepatotoxicity. Other risks include bone marrow reticulin formation and a risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts.
For more information, visit the Ligand Web site.