The European Commission has approved Sanofi SA's (NASDAQ: SNY) Aubagio (teriflunomide) 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 3 TERIKIDS study.
Aubagio was initially approved in the European Union in 2013 for the treatment of adult patients with RRMS, and the European Commission's approval for the pediatric indication provides an additional year of marketing protection in the European Union.
Last week, the FDA rejected the Aubagio application for RRMS in children and adolescents, ages 10 to 17.
"The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time."
The FDA has updated the Aubagio label to include additional safety information based on clinical studies in pediatric MS. Still, its indicated use (limited to patients ages 18 and older) remains unchanged.
Price Action: SNY shares are down 1.59% at $52.39 during the market trading session on the last check Friday.
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