ARTICLE | Company News

FDA grants Priority Review to Promacta sNDA

May 1, 2014 12:43 AM UTC

Ligand Pharmaceuticals Inc. (NASDAQ:LGND) said FDA accepted and granted Priority Review for an sNDA from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to expand the label of Promacta eltrombopag to include treatment of cytopenias in patients with severe aplastic anemia with an insufficient response to immunosuppressive therapy. Promacta has breakthrough therapy designation from FDA for the indication, a rare disorder in which the bone marrow fails to make enough new blood cells. GSK declined to disclose the PDUFA date, but said FDA granted Priority Review designation on April 25. GSK plans to submit a regulatory application to expand the European label to include the severe aplastic anemia indication next half.

Promacta is approved in 100 countries to treat thrombocytopenia in patients with chronic idiopathic thrombocytopenic purpura (ITP) and in 43 countries, including the U.S. and those of the EU, to treat thrombocytopenia in patients with chronic HCV infection. Outside of the U.S., the drug is known as Revolade. ...