| Novartis has been informed of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with relapsing MS (RMS) treated with Gilenya without prior exposure to natalizumab treatment. The patient also has a history of colorectal cancer treated with chemotherapy and radiation treatment in the past as well as Crohn's disease (an inflammatory bowel condition). The diagnosis of PML was based on suggestive clinical symptoms, MRI findings and tests for JC (John Cunningham) virus. Health Authorities have been informed of the case. Novartis is in active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML. Novartis recently updated the Gilenya prescribing information, in collaboration with Health Authorities, to increase vigilance for PML. With more than 125,000 patients treated with Gilenya and 240,000 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 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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