The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Gilenya (fingolimod; Novartis) capsules regarding its Risk Evaluation and Mitigation Strategy (REMS) assessment. 

The sNDA proposed the elimination of the approved REMS for Gilenya and upon review, the FDA has determined that a REMS is no longer required. 

The FDA initially approved the REMS for Gilenya in September 2010 with the most recent update approved in May 2015. The latest modification consisted of a communication plan and a timetable for submission of assessments of the REMS.  

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The communication plan and assessment submitted in April 2016 demonstrated that the plan met its goals and the FDA determined that it was no longer necessary to include it as a component of the approved REMS to ensure that the drug’s benefits outweighed the risks.

Gilenya, a sphingosine 1-phosphate receptor modulator, is indicated for relapsing forms of multiple sclerosis (MS): to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Gilenya is available as 0.5mg hardgel capsules in 30-count bottles and in 7-count blister cards.

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