The Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab; Novartis) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Kesimpta, a CD20-directed cytolytic monoclonal antibody, is the first B-cell therapy that is intended for patient self-administration by subcutaneous injection. It is believed to work by binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes, thereby inducing B-cell lysis and depletion.
The approval was based on efficacy and safety data from the phase 3 ASCLEPIOS I and II trials that compared ofatumumab with teriflunomide, a pyrimidine synthesis inhibitor, in 1882 adult patients with RMS. Findings from the studies showed ofatumumab significantly lowered the annualized relapse rate (primary end point) compared with teriflunomide. Additionally, ofatumumab significantly reduced the risk of 3-month confirmed disability progression vs teriflunomide, as well as the number of T1 gadolinium-enhancing lesions and the rate of new or enlarging T2 lesions. As for safety, ofatumumab demonstrated a similar profile to teriflunomide with the most common adverse reactions being upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.
“In the key clinical studies, this breakthrough treatment produced a profound reduction in new brain lesions, reducing relapses and slowing underlying disease progression,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center.”
Kesimpta is supplied as 20mg/0.4mL solution in single-dose prefilled syringes or Sensoready ® pens. It is expected to be available in early September 2020.
Ofatumumab is also marketed under the brand name Arzerra and is approved for the treatment of chronic lymphocytic leukemia via intravenous infusion.
For more information visit novartis.com.
- FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. https://novartis.gcs-web.com/FDA-approves-Novartis-Kesimpta-ofatumumab-the-first-and-only-self-administered-targeted-B-cell-therapy-for-patients-with-relapsing-multiple-sclerosis. Accessed August 21, 2020.
- Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2020.