Novartis gets approval for Revolade as SAA therapy in Europe

The European Commission has approved Revolade (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pre-treated and are unsuitable for hematopoietic stem cell transplant.

Revolade, also marketed as Promacta in the USA, was acquired by Swiss pharma giant Novartis (NOVN: VX) as part of the three-part asset swap with GlaxoSmithKline (LSE: GSK) which completed earlier this year and involved the Swiss firm acquiring the GSK oncology business for around $16 billion (The Pharma Letter March 2). In 2014, GSK posted sales of £231 million ($356 million at current exchange rates) for the eltrombopag. The UK drug major filed for European approval in the SAA indication earlier this year (The Pharma Letter February 6).

"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," said Alessandro Riva, global head, Novartis Oncology Development and Medical Affairs, adding: "Revolade helps address an unmet need in this community and underscores our commitment to patients affected by rare diseases."