FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Expands Novartis MS Drug to Cover Pediatric Patients

May 16, 2018

The FDA expanded its approval of Novartis’ Gilenya to treat relapsing multiple sclerosis in children aged 10 and older.

The drug was first approved by the agency in 2010 for adults with relapsing multiple sclerosis. The expanded indication marks the first FDA approval of a drug to treat MS in pediatric patients.

The FDA also granted breakthrough therapy and priority review designations for the indication. The expanded indication was based on a clinical trial that found 86 percent of patients receiving Gilenya remained relapse-free two years after treatment.

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