BASEL (dpa-AFX) - Swiss drug maker Novartis AG (NVS) announced that the European Commission has approved its Revolade (eltrombopag) 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 (IST).
Revolade is the first approved therapy in the EU for patients with SAA who have not responded to other treatments.
SAA is a rare blood disorder where the bone marrow does not make enough red blood cells, white blood cells and platelets. It has limited treatment options. Treatment of SAA is focused on increasing the number of healthy cells in the blood (blood cell count).
The approval is based on the results of a pivotal open-label Phase II study (ELT112523) and two supporting Phase II studies (ELT116826 and ELT116643) conducted by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
The pivotal study demonstrated a hematologic response of 40 percent in SAA patients treated with Revolade who had an insufficient response to IST.
The European Commission approval applies to all 28 EU member states plus Iceland, Norway and Liechtenstein. In August of 2014, eltrombopag (marketed as Promacta in the U.S.), was approved by the U.S. 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.
Revolade is already approved in more than 100 countries worldwide for different indications.
Copyright RTT News/dpa-AFX