Novartis had submitted an application in February for the extension of the marketing authorization to include the treatment of the rare disease mastocytosis. Mastocytosis is a disease in which mast cells accumulate excessively in the skin and bone marrow and other organs such as liver, spleen and intestine. It has a poor long term outcome.
The agency said that Novartis had withdrawn the extension because it believed there was limited data about the benefits of Glivec for the treatment of systematic mastocytosis.
Glivec was first authorized in the European Union on 7 November 2001. It is currently indicated for treatment of chronic myeloid leukemia and other indications and is one of Novartis’ biggest selling products.
Imatinib mesilate was designated an orphan medicinal product for the treatment of mastocytosis on 26 August 2005.