BRIEF—FDA issues CRL for Aubagio submission for children

The US Food and Drug Administration has issued a Complete Response Letter regarding the supplemental New Drug Application (sNDA) for Aubagio (teriflunomide) for children and adolescents aged 10 to 17 years with relapsing forms of multiple sclerosis, the drug’s maker, Sanofi, announced on Friday.

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.

This is a disappointment for Sanofi, which has seen increased competition in the US multiple sclerosis market. In the first quarter of this year, Aubagio posted sales of 500 million euros ($605 million), which was 7.6% less than in the like 2020 period.