Ligand Pharma: Revolade Recommended By CHMP For EU Approval To Treat SAA

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) announces the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) adopted a positive opinion for Revolade (eltrombopag), a Novartis product, for the treatment of adult patients with acquired severe aplastic anemia or SAA who were either refractory to prior immunosuppressive therapy or IST or heavily pretreated and are unsuitable for hematopoietic stem cell transplantation.

SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells and platelets.

Two out of every one million people in Europe and North America are diagnosed with aplastic anemia per year, a portion of which are severe cases. The exact cause of the disease is still unknown, but most cases of SAA are believed to be triggered by an autoimmune reaction where the body attacks blood-forming stem cells located in the bone marrow. As a result, patients with SAA are at risk for life-threatening infections or bleeding.

In August of 2014, eltrombopag (marketed as Promacta in the USA), was approved by the US Food and Drug Administration for once-daily use in patients with SAA who have had an insufficient response to IST. Eltrombopag is also approved for SAA in Canada.