Table 3.

FDA-required pediatric MS studies.

Compound	Abbreviated study title	FSR
Glatiramer acetate (Copaxone)	R C PG superiority study in 10–17 year olds on S&E compared with an appropriate control for the treatment of relapsing forms of MS	2021
Teriflunomide (Aubagio)	R C PG superiority trial on single and multiple dose PK, S&E compared with an appropriate control for the treatment of relapsing forms of MS	2017
Fingolimod (Gilenya)	24-month R AC PG study on single and multiple dose PK, S&E compared with IFβ1a intramuscularly (Avonex) for the treatment of relapsing remitting MS. E portion of study to be designed to show superiority over AC	2016
Dimethyl fumarate (Tecfidera)	R C PG superiority trial in 10–17 year olds on PK, S&E compared with an appropriate control for the treatment of relapsing forms of MS	2020

AC, active controlled; C, controlled; E, efficacy; FSR, final study report; IFβ, interferon β; MD, multiple dose; MS, multiple sclerosis; PG, parallel group; PK, pharmacokinetics; R, randomized; S&E, safety and efficacy.