Novartis’ Revolade approved in Europe for severe aplastic anaemia

Novartis has announced that the European Commission has approved its drug Revolade as a first-in-class therapy for patients with severe aplastic anaemia.

The product has been ratified for use among patients who are either refractory to prior immunosuppressive therapy, or have been heavily pretreated and are unsuitable for haematopoietic stem cell transplant.

Revolade has demonstrated its efficacy in the treatment of this condition in a number of phase II clinical trials. It becomes the first approved therapy in the EU for patients with severe aplastic anaemia who have not responded to other treatments.

Dr Alessandro Riva, global head of Novartis oncology development and medical affairs, said: "Today's approval from the European Commission is important news for adults in the EU with severe aplastic anaemia, who now have an alternative to standard therapies that have not provided sufficient benefit."

The condition is a blood disorder where the bone marrow does not make enough red blood cells, white blood cells and platelets. Patients with this disease are at a high risk for life-threatening infections or bleeding.