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Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kesimpta (Ofatumumab) as an subcute preparation for the treatment of multiple sclerosis (RMS), including clinical isolation syndrome, relapse remission and active secondary progression.
photo source: Kesimpta is an all-human anti-CD20 monoantigen that shows excellent efficacy and similar safety compared to Teflon.
FDA approval makes Kesimpta the first and only B-cell therapy that patients can inject at home, once a month through Sensoready auto-injection pens.
Kesimpta's approval is based on the results of Phase III clinical studies asclePIOS I and II studies, which showed that Kesimpta significantly reduced annual recurrence rate (ARR, primary endpoint) and confirmed disability progressity (CDP) after 3 months.
the results of two studies were most recently published in the August 6, 2020 issue of the journal NEJM.
Ofatumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med 2020;383:546-57. DOI: 10.1056/NEJMoa1917246 Kesimpta provides patients with the flexibility to self-dosing through monthly subsempic dosing without having to go to an infusion center.
positive results from the APLIOS study in phase II of the study showed that RMS patients were biologically equivalent to Kesimpta injections with pre-installed syringes and Sensoready pens.
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