Gilenya Safety Update

Greater than 71,000 patients have been treated with Gilenya globally.  Gilenya was FDA-approved three years for relapsing multiple sclerosis in September of 2010.  Gilenya has been demonstrated to reduce relapses by over half compared to placebo and compared to Avonex.   Patients on Gilenya were less likely to progress in disability and had 82% less active (contrast) MRI lesions.  In three different trials, Gilenya reduced the likelihood of brain shrinkage called atrophy compared to placebo and Avonex.

The first case of PML unrelated to recent Tysabri use was recently reported in a patient treated with Gilenya.   PML (progressive multifocal leukoencephalopathy)  is a serious brain viral infection that can occur in patients taking certain medications or have a weakened immune system.  The patient has had an extremely aggressive disease course of possible MS with extensive spinal cord and atypical brain lesions prior to Gilenya treatment which worsened over one-half years.  The patient was treated with interferon and an immunosuppressive medication (azathioprine) for 1 month prior to 7 months of Gilenya.  Based on review of the MRI imaging, the patient may have had PML prior to Gilenya initiation. The risk of PML may have been further increased by approximately monthly courses of intravenous steroids with oral taper prior to and on Gilenya treatment.