Teriflunomide: Pediatric First Approval

Teriflunomide (Aubagio(R)), which was developed by Sanofi, is an oral immunomodulatory agent targeting the mitochondrial enzyme dihydroorotate dehydrogenase and available to adults to treat relapsing-remitting multiple sclerosis (MS). On 18 June 2021, teriflunomide received its first approval in this indication in pediatric patients aged >= 10 years in the EU. This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.

Automated summary

Teriflunomide is an oral immunomodulatory agent developed by Sanofi for treating multiple sclerosis, and recently received approval in the EU for pediatric patients aged >= 10 years. This marks a significant milestone in the development of teriflunomide for relapsing-remitting MS in children.