Novartis said it can be used to treat adults with SAA who are either refractory to before immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.
The approval is based on a pivotal mid-stage study that showed a 40% hematologic response in SAA patients treated with Revolade who failed to respond to IST.
SAA is a rare and life-threatening blood disorder where the bone marrow does not make required number of red and white blood cells and platelets. It affects less than 2,000 Europeans per year.
Novartis Oncology Development and Medical Affairs global head Alessandro Riva said: "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.
"Revolade helps address an unmet need in this community and underscores our commitment to patients affected by rare diseases."
Revolade is approved in over 100 countries to treat thrombocytopenia in adults with chronic immune ideopathic thrombocytopenic purpura who have had an inadequate response or are intolerant to other treatments.
It is cleared in more than 45 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to start and maintain interferon-based therapy.
Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.