Novartis Receives FDA Approval for Kesimpta in Pediatric Multiple Sclerosis

Novartis today announced that the FDA has approved Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (MS) in patients aged 10 years and older. This approval makes Kesimpta the first self-administered subcutaneous anti-CD20 therapy approved for pediatric MS. In the Phase 3 CELIA trial, Kesimpta demonstrated significant reductions in annualized relapse rate and MRI lesion activity in pediatric patients with relapsing MS. The self-administered monthly injection offers a convenient treatment option for pediatric patients and their caregivers. This approval expands Kesimpta's use into the pediatric MS population.