Novartis Announces FDA Approval of Kesimpta (ofatumumab), the First Self-Administered Subcutaneous Anti-CD20 Therapy for Relapsing Multiple Sclerosis

Novartis Announces FDA Approval of Kesimpta (ofatumumab) for Relapsing Forms of Multiple SclerosisNovartis announced today that the U.S. Food and Drug Administration (FDA) has approved Kesimpta (ofatumumab) as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The press release noted that Kesimpta is the first B-cell-targeted therapy that allows patients to self-administer a monthly dose at home using the Sensoready autoinjector pen, thereby facilitating disease management for patients.

Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS) that impairs normal function of the brain, optic nerves, and spinal cord through inflammation and tissue damage. The progression of MS leads to increasing loss of physical functions (e.g., walking) and cognitive functions (e.g., memory). There are three main types of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). RRMS is characterized by clearly defined episodes of relapse and remission, i.e., relapses, attacks, or worsening of symptoms, followed by periods of partial or complete recovery. Worldwide, there are approximately 2.3 million people with MS, and about 85% of them are initially diagnosed with RRMS.

Image source: Reference [2]

Ofatumumab is a fully human monoclonal antibody targeting CD20. It works by binding to CD20 on the surface of B cells, thereby clearing B cells from the bloodstream. It was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia (CLL), administered via high-dose intravenous infusion by healthcare providers. Given the pivotal role of B cells in autoimmune diseases, Novartis initiated a novel development program to investigate the efficacy of ofatumumab in treating relapsing multiple sclerosis (RMS). The clinical development program for ofatumumab in RMS spanned 10 years and involved more than 2,300 patients worldwide. Kesimpta operates through a unique mechanism of action, and its dosing regimen, specifically designed for RMS, plays a critical role in therapeutic outcomes. This differs from the dosing regimen and route of administration previously approved for the CLL indication.

The approval of Kesimpta was based on the results from the Phase 3 clinical trials ASCLEPIOS I and II. In these studies, Kesimpta significantly reduced the annualized relapse rate (ARR) and confirmed disability progression, and decreased active or new brain lesions compared with approved oral therapies. The results of these two studies were recently published in The New England Journal of Medicine on August 6, 2020.

References:

[1] FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Retrieved August 20, 2020, from https://www.novartis.com/news/media-releases/fda-approves-novartis-kesimpta-ofatumumab-first-and-only-self-administered-targeted-b-cell-therapy-patients-relapsing-multiple-sclerosis

[2] Understanding relapsing forms of multiple sclerosis. Retrieved August 20, 2020, from https://novartis.gcs-web.com/static-files/45572026-e420-4ed7-9f22-2655836a9748

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