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

In the CRL, the FDA noted that the “data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time.” The labeling for Aubagio has been updated to include 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 who received teriflunomide, respectively, compared with 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, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Reference

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