EC Oks Novartis’ Revolade for Severe Aplastic Anemia
The European Commission has approved Novartis' Revolade (eltrombopage) for treating severe aplastic anemia (SAA). The European Commission approval applies to all 28 European member states plus Iceland, Norway, and Liechtenstein. The drug was earlier approved in August 2014 in the United States.
In Europe, Revolade was specifically approved for patients either refractory to prior immunosuppressive therapy (IST) or heavily pretreated and are unsuitable for hematopoietic stem cell transplant. The drug was approved by the US Food and Drug Administration in August of 2014 under the trade name Promacta for once-daily use in patients with SAA who have had an insufficient response to IST and was also recently approved for the treatment of children one year and older with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Revolade is approved in over 100 countries worldwide for treating adult patients with ITP who have had an inadequate response or are intolerant to other treatments, and in over 45 countries worldwide treating thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.