NeurologyNovartis

Novartis Receives FDA Approval for Kesimpta in Pediatric Multiple Sclerosis

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Biotechnology Media Insights

Editorial Team · August 3, 2025

Novartis announces FDA approval of Kesimpta (ofatumumab) for children and adolescents aged 10 years and older with relapsing forms of multiple sclerosis.

Neurology brain research laboratory with advanced imaging equipment

Novartis today announced that the FDA has approved Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in children and adolescents aged 10 years and older. The approval was based on results from the Phase 3 NEOS trial, which demonstrated significant reductions in annualized relapse rates and MRI lesion activity in pediatric patients.

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