EMA Advisory Committee Recommends Novartis’ Severe Anemia Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Novartis’ Revolade (eltrombopag), a drug to treat a severe form of anemia. The drug was approved for treating adults with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST) and are not eligible to receive a hematopoietic stem-cell transplant. SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.
The European Commission will review the CHMP recommendation and is expected to deliver its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway, and Liechtenstein. In August of 2014, eltrombopag (marketed as Promacta in the United States), 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.