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

  • Multiple sclerosis
  • Relapsing Multiple Sclerosis
  • Secondary progressive multiple sclerosis

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.

Music and Memory Program Decreased Need for Antipsychotic Treatment in Dementia 

Previous News Article

Rimegepant for Acute Migraine Treatment Is Well Tolerated by Individuals Taking CGRP Monoclonals for Migraine Prevention

Next News Article
This Month's Issue
Movement Disorders in Antiphospholipid Syndrome & Systemic Lupus Erythematosus

Danielle S. Shpiner, MD; Crystal Dixon, MD; Melissa R. Ortega, MD; and Henry Moore, MD

Utility of Autoantibody Profiles

Shailee S. Shah, MD, and Andrew McKeon, MD

Autoimmune Movement Disorders

Jill M. Giordano Farmer, DO