Teriflunomide Ped - Summary Slide.PNG (168.35 kB)

Teriflunomide: Pediatric First Approval

online resource

posted on 2021-09-16, 02:53 authored by Julia Paik

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here

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 forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS, depending on the local label. 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 approval, disease modifying therapy for the first-line treatment of relapsing-remitting MS in pediatric patients aged ≥ 10 years.