FDA grants Breakthrough Therapy designation to GSK's Promacta/Revolade for treatment of cytopenias
Published on February 3, 2014 at 8:40 AM
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that the U.S. Food and Drug Administration (FDA) has granted its partner GlaxoSmithKline plc (LSE:GSK) Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for the treatment of cytopenias in patients with severe aplastic anemia (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. "We congratulate the global Promacta/Revolade development team at GSK, and commend them for their continued scientific and regulatory progress."
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 (IST). Of those patients unresponsive to initial IST, approximately 40% die from infection or bleeding within five years of their diagnosis.
The Breakthrough Therapy designation was based on the results from an open-label, Phase II National Institute of Health (NIH) study (09-H-0154) of eltrombopag in 43 heavily pre-treated SAA patients with an insufficient response to IST.
Ligand Pharmaceuticals Incorporated