Gilenya Label Updated to Include T1 Gd-Enhancing MRI Data

Novartis announced that the FDA has approved a supplemental New Drug Application (sNDA) for Gilenya (fingolimod capsules) that includes T1 Gd-enhancing magnetic resonance imaging (MRI) data. Gilenya, a sphingosine 1-phosphate receptor modulator, is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. T1 Gd-enhancing lesions are areas of active inflammation in the central nervous system and represent a key marker of disease activity in patients with MS.

As a result of the approved sNDA, the Clinical Studies section of the Gilenya labeling has been updated to include T1 MRI findings from the 12 month TRANSFORMS and 24 month FREEDOMS studies. At 12 months, the mean number of Gd-enhancing T1 lesions was significantly lower for patients treated with Gilenya 0.5mg compared to patients taking interferon beta-1a IM; 0.2 vs. 0.5 respectively (P<0.001). Gilenya 0.5mg demonstrated a similar effect at 24 months when compared to placebo; 0.2 vs. 1.1, respectively (P<0.001).

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