EU approves extended approval of Aubagio for pediatric patients with relapsing-remitting multiple sclerosis.- Sanofi/Genzyme
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)>
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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