*3.1. Fingolimod*

Fingolimod was the first oral medication, approved in patients with relapsing forms of MS. The therapeutic efficacy of FGM for RMS was initially established in two pivotal, phase III, double-blind, randomized clinical trials of adults, comparing FGM to placebo (FREEDOMS) and comparing FGM to IFN-β-1a (TRANSFORMS). This was followed by the phase III extension studies FREEDOMS II and extended TRANSFORMS. The regulatory approval for use of FGM in the treatment of RRMS in children ages 10–17 years of age in 2018 [91] followed the results of the pivotal trial, PARADIGM [92].
