GlaxoSmithKline Gets FDA Breakthrough Therapy Designation For Promacta/Revolade

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) said that the U.S. Food and Drug Administration or FDA has granted its partner GlaxoSmithKline plc (GSK.L) Breakthrough Therapy designation for Promacta/Revolade or eltrombopag for the treatment of cytopenias in patients with severe aplastic anemia or SAA, who have had insufficient response to immunosuppressive therapy.

"Promacta continues to be the basis of ground breaking and promising science in important areas with significant unmet medical needs" said John Higgins, President and CEO of Ligand.

SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are no approved therapies available for SAA patients who are unresponsive to initial immunosuppressive therapy or IST. Out of those patients unresponsive to initial IST, nearly 40% die from infection or bleeding within 5 years of their diagnosis.

The Breakthrough Therapy designation was based on the results from an open-label, Phase II National Institute of Health or NIH study of eltrombopag in 43 heavily pre-treated SAA patients with an insufficient response to IST.