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EC Approves Sanofi's Aubagio For Treatment Of Pediatric Patients With RRMS

French drug maker Sanofi (SNY) said that the European Commission has approved Aubagio or teriflunomide for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis or RRMS.

The approval was based on data from the Phase 3 TERIKIDS study. The approval confirmed 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.

Multiple sclerosis is a chronic neurodegenerative disease in which a person's immune system causes damage to the brain and spinal cord.

Last week, the U.S. Food and Drug Administration had rejected an application requesting the expansion of Aubagio for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis.

The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. The FDA updated the Aubagio label to include safety data from the pediatric clinical trial program. The indicated use of Aubagio in patients 18 years and older remains unchanged, Sanofi said in a press release last week.

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