| 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). The patient is currently hospitalized. The diagnosis was based on suggestive clinical symptoms, MRI findings and tests for JC (John Cunningham) virus. Novartis is in active discussions with external advisors and Health Authorities to review details of this case and the role of various risk factors contributing to the development of PML. With more than 119,000 patients treated with Gilenya and 218,500 patient years of exposure in both clinical trials and post-marketing setting, Novartis continues to stand behind the positive benefit-risk profile of Gilenya in relapsing MS. Novartis International AG Investor Relations |
Novartis Global Investor Relations / General phone: +41 61 324 79 44
Samir Shah / Global Head Investor Relations +41 61 324 79 44
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