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Sanofi recently announced that the European Commission (EC) has approved the expansion of Aubagio (teriflunomide, teriflunomide) for the first-line treatment of relapsing-remitting multiple sclerosis (RRMS) pediatrics aged 10-17 years Patient
Aubagio was approved for marketing in the United States and the European Union in September 2012 and August 2013 for the treatment of adult patients with RRMS
It is estimated that MS affects approximately 2.
Erik Wallstrom, head of neurology development at Sanofi Genzyme, said: “Pediatric MS is still an important field with unmet medical needs
The efficacy and safety of Aubagio in pediatric patients:
The Phase 3 TERIKIDS study (NCT02201108) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that included 166 relapsing-remitting multiple sclerosis (RRMS) pediatric patients from 22 countries
In the study, 109 patients were randomly assigned to the Aubagio group and 57 patients were randomly assigned to the placebo group
——In terms of the primary endpoint, numerically, the risk of clinical recurrence in the Aubagio group was reduced by 34% compared with the placebo group, but no significant difference was reached
In a pre-specified sensitivity analysis of the composite endpoint of the time to first disease activity (the time to first confirming clinical recurrence or the time to switch to open-label treatment with high MRI activity), compared with placebo , Aubagio will reduce the risk of first confirmed clinical recurrence or switch to open-label therapy due to high MRI activity by 43% and delay (median time: 72.
——In terms of key secondary endpoints, compared with placebo, Aubagio significantly reduced the number of T1 gadolinium-enhanced (Gd+T1) lesions on MRI scans by 75% (p<0.
In this study, Aubagio was well tolerated in the pediatric population and its safety was controllable
Original source: European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
