Sanofi’s Aubagio (teriflunomide) Receives EC’s Approval as First Oral MS Therapy for 1L Treatment with Relapsing-Remitting Multiple Sclerosis in Children and Adolescents

Shots:

• The EC approval is based on a P-III TERIKIDS study evaluating Aubagioin vs PBO in 166 pediatric patients aged 10-17yrs. with RRMS across 22 countries globally, where a screening period (4wks.) is followed by a double-blind treatment period for ~96wks.
• The 1EPs is not significant with numerically a lower risk (-34%) of clinical relapse (75.3 vs 39.1wks.), switches were more frequent (14% vs 26%). In the pre-specified sensitivity analysis, teriflunomide reduced the time to clinical relapse or switch due to high MRI activity by 43% (72.1 vs 37.0 wks.)
• Aubagio is approved in 80+ countries for RRMS with additional marketing applications under review by regulatory authorities globally

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