Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ligand Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted its partner GlaxoSmithKline (GSK) Priority Review 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.
Subscribe to our email newsletter
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).
In February 2014, Ligand announced that GSK had gained Breakthrough Therapy designation for Promacta in Severe Aplastic Anemia. Also in February 2014, GSK announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Promacta for the treatment of cytopenias (a reduction in blood cells) in patients with SAA who have had an insufficient response to IST.
The sNDA is 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.