EU Approves Sanofi’s Aubagio for Children and Adolescents With MS

The EU has approved Sanofi’s Aubagio (teriflunomide) for use in children and adolescents with multiple sclerosis -- just days after the FDA issued the company a Complete Response Letter  regarding its supplemental New Drug Application (sNDA) for Aubagio, rejecting its use in children and adolescents ages 10 to 17 years and requesting more pediatric data.

The European Medicines Agency’s Committee for Medicinal Products for Human Use decided that Aubagio’s benefits are far greater than its risks and recommended that it be approved for use in children and teens. The drug is a pyrimidine synthesis inhibitor that helps prevent immune cells from quickly multiplying, decreasing inflammation.

Aubagio is approved by the FDA for treating relapsing forms of MS in adults, but the FDA deemed the data submitted with the sNDA for children and teens “not sufficient to obtain approval of an indication in the pediatric population at this time,” Sanofi said.