FDA rejects Aubagio sNDA for pediatric relapsing MS indication

Subjects ” multiple sclerosis

The Food and Drug Administration (FDA) has issued Sanofi a Complete Response Letter (CRL) regarding the Supplementary New Drug Application (sNDA) for Aubagio® (teriflunomide), which affects children and adolescents between the ages of 10 and 17 with relapsing forms of multiple intended to include sclerosis (MS).

In the GRL, the FDA stated that “the data presented at this point in time are insufficient to obtain approval for an indication in the pediatric population”. The Aubagio label has been updated to include safety data from the pediatric clinical study program. In the pediatric study (N = 166), pancreatitis and increased / abnormal blood creatine phosphokinase levels were reported in 1.8% and 6.4%, respectively, of patients receiving teriflunomide, compared with no patient 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 MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

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reference

1. Sanofi announces the approval of Aubagio® (teriflunomide) for children and adolescents with relapsing remitting multiple sclerosis in the USA [press release]. Cambridge, MA; Sanofi. 06/11/2021.
2. Aubagio [packet insert]. Cambridge, MA; Sanofi. 2021.

neuropean

This article originally appeared on MPR

Subjects:

Multiple Sclerosis Pediatrics Recurrent Remitting Multiple Sclerosis Treatments

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Aubagio rejects sNDA for pediatric relapsing MS indication for further information on FDA

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Aubagio rejects sNDA for pediatric relapsing MS indication for further information on FDA

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