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.
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.