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# Novartis’ Kesimpta Approved for Multiple Sclerosis
- URL: https://www.fdaweb.com/novartis-kesimpta-approved-for-multiple-sclerosis/
- Published: 2020-08-20T12:00:00.000Z
- Updated: 2026-09-14T16:25:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147480

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.