GSK wins FDA priority review for Promacta supplemental new drug application

GlaxoSmithKline, Ligand Pharmaceuticals’ partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection.

Eltrombopag, known by the brand name Promacta in the US and Revolade in the European Union and other countries, is indicated for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia.

The risks associated with Promacta include hepatotoxicity, bone marrow reticulin formation and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts.

A priority review designation is given to drugs that are considered to offer major advances in treatment or provide a treatment where no adequate therapy exists, if approved.

Under the Prescription Drugs User Fee Act, the goal for completing a priority review is six months. Ligand is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure.