The European Commission (EC) has approved Sanofi’s Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS).
Based on data from the Phase 3 TERIKIDS study, the approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
“Pediatric multiple sclerosis remains an area of significant unmet medical need,” said Erik Wallström, Therapeutic Area Head, Neurology Development at Sanofi Genzyme.
“The European approval of Aubagio in paediatrics means young people with MS have a new treatment option, and importantly – one that can offer meaningful improvement in managing this serious disease.”
Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the paediatric indication provides an additional year of marketing protection in the European Union.