Teriflunomide: Pediatric First Approval

Paediatr Drugs. 2021 Nov;23(6):609-613. doi: 10.1007/s40272-021-00471-1.

Abstract

Teriflunomide (Aubagio®), 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.

Publication types

  • Review

MeSH terms

  • Adult
  • Child
  • Crotonates* / adverse effects
  • Humans
  • Hydroxybutyrates
  • Immunologic Factors
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Nitriles
  • Toluidines / adverse effects

Substances

  • Crotonates
  • Hydroxybutyrates
  • Immunologic Factors
  • Nitriles
  • Toluidines
  • teriflunomide