FDA Rejects Aubagio sNDA for Pediatric Relapsing MS Indication

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The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Sanofi regarding the additional New Drug Application (sNDA) for Aubagio® (teriflunomide) for children and adolescents 10 to 17 years of age with recurrent multiple sclerosis (MS).

In the CRL, the FDA noted that the “data submitted at this time was not sufficient to obtain approval of an indication in the pediatric population.” The labeling for Aubagio has been updated with safety data from the pediatric clinical trial program. In the pediatric study (N=166), pancreatitis and elevated/abnormal blood creatine phosphokinase were reported in 1.8% and 6.4% of patients receiving teriflunomide, respectively, compared to no patients in the placebo group.

Aubagio, a pyrimidine synthesis inhibitor, is currently indicated for the treatment of adults 18 years of age and older with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.


Sanofi provides an update on the filing of Aubagio® (teriflunomide) for children and adolescents with relapsing-remitting multiple sclerosis in the US. [press release]. Cambridge, MA; Sanofi. June 11, 2021.Aubagio [packet insert]. Cambridge, MA; Sanofi. 2021.


Multiple Sclerosis Neurological Disorders Pediatrics

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