Posted by Michael Wonder on 11 Jun 2021
Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S
11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for Aubagio (teriflunomide) for children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the paediatric population at this time. The FDA updated the Aubagio label to include safety data from the paediatric clinical trial program.
