2 September 2015 - Novartis announced today that the European Commission has approved Revolade (eltrombopag olamine) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.

"Today's approval from the European Commission is important news for adults in the EU with severe aplastic anemia, who now have an alternative to standard therapies that have not provided sufficient benefit," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Revolade helps address an unmet need in this community and underscores our commitment to patients affected by rare diseases."

SAA is a blood disorder where the bone marrow does not make enough red blood cells, white blood cells and platelets. Two out of every one million people in Europe 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.

For more details, go to: https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-new-revolade®-use-first-class-therapy-patients

MAESTrO Insight: The FDA designated eltrombopag olamine (Promacta) as a breakthrough therapy for this indication.