Novartis Statement on Reported Case of PML
Novartis has been informed of a patient with progressive multifocal leukoencephalopathy (PML). The patient had been diagnosed with ulcerative colitis (an autoimmune bowel disease) in 2011 and had been treated with oral mesalazine since February 2011. At the end of 2012, the patient started treatment with Gilenya® (fingolimod) for the management of relapsing MS (RMS). This is the second case of PML in an MS patient being treated with Gilenya who did not haveprevious use of Tysabri® (natalizumab).