FDA Approves Ofatumumab—First and Only Self-administered B-cell Therapy for Relapsing MS

The Food and Drug Administration (FDA) has approved ofatumumab (Kesimpta; Novartis) as an subcutaneous autoinjection for treatment of relapsing forms of multiple sclerosis (RS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive MS (aSPMS), in adults. Ofatumumab is a targeted precisely dosed and delivered B-cell therapy that has shown superior efficacy compared with teriflunomide (Aubagio; Sanofi, Bridgewater, NJ) with a similar safety profile. Ofatumumab is a first-choice treatment option for individuals with relapsing forms of MS. Ofatumumab is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready autoinjector pen.

Approval was based on results from the phase 3 Asclepios 1 and 2 studies (NCT02792218 and NCT02792231), in which ofatumumab (20 mg/month, subcutaneous) vs teriflunomide (14 mg/day, oral):

• significantly reduced the annualized relapse rate (ARR) by 51% (0.11 vs 0.22) and 59% (0.10 vs 0.25)(P<.001 in both studies)
• conferred a 34.4% (P<.002)relative risk reduction in 3-month confirmed disability progression
• reduced the number of gadolinium-enhancing (Gd+) T1
• reduced the number of new or enlarging T2 lesions

Results from these 2 studies were recently published in the August 6, 2020 issue of The New England Journal of Medicine.

Traditionally, B-cell treatments, which bind to and deplete B-cells associated with disease activity in MS, have predominantly been available in hospitals or infusion treatment centers, which can add costs to the healthcare system and present a lifestyle burden for some participants. Ofatumumab provides the flexibility of self-administration via once-monthly subcutaneous dosing without premedication, eliminating the need to travel to an infusion center. 

The positive results from an open-label phase 2 study to determine the bioequivalence of subcutaneous delivery of ofatumumab via a prefilled syringe and a Sensoready pen in participants with RMS—and the Asclepios studies show ofatumumab to be a highly effective B-cell therapy that can be easily self-administered at home.