Novartis’ Kesimpta Approved for Multiple Sclerosis

FDA has approved a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug is described as a targeted, precisely dosed and delivered B-cell therapy that can be self-administered once monthly at home via the Sensoready autoinjector pen.

Ofatumumab was first approved in 2009 for treating chronic lymphocytic leukemia through a high-dose intravenous infusion by a healthcare provider. The new approval is based on data from the Phase 3 ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority versus teriflunomide in significantly reducing the annualized relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions, Novartis says.