FDA Rejects Expansion of Aubagio for Pediatric MS

FDA Rejects Expansion of Aubagio for Pediatric MS

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FDA Rejects Expansion of Aubagio for Pediatric MS

The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time,” Sanofi, the therapy’s developer, said in a press release. The FDA has updated the Aubagio label to include additional…

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