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EU approves extended approval of Aubagio for pediatric patients with relapsing-remitting multiple sclerosis.- Sanofi/Genzyme

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Published:21st Jun 2021
The European Commission has approved Aubagio (teriflunomide), from Sanofi/Genzyme, for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase III 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.

Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union.

In the TERIKIDS study pre-specified sensitivity analysis of the composite endpoint of time to first clinical relapse or high MRI activity meeting study criteria to switch to open label, teriflunomide significantly reduced the time to clinical relapse or switch due to high MRI activity by 43% relative to placebo (median time: 72.1 vs 37.0 weeks; HR [95% CI] 0.57 [0.37, 0.87] P=0.04). Key secondary endpoints showed teriflunomide significantly reduced the number of T1 gadolinium (Gd) -enhancing lesions per MRI scan (relative reduction 75%; P<0.0001) as well as the number of new and enlarging t2 lesions per mri scan (relative reduction 55%, p="0.0006)." in the study, teriflunomide was well tolerated and had a manageable safety profile in the pediatric population.></0.0001)>

Condition: Multiple Sclerosis
Type: drug

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