2020-08-23| Trials & Approvals

Novartis’ Kesimpta Notches FDA Approval as Targeted B-cell Therapy for Patients with Relapsing MS

by Tulip Chakraborty
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With this, the drug becomes the first and only self-administered, targeted B-cell therapy to get approval for relapsing forms of multiple sclerosis (RMS).

By T. Chakraborty, Ph.D.

Multiple sclerosis (MS) is a debilitating and chronic inflammatory disease that affects the central nervous system, brain, optic nerves, and spinal cord. The immune system, which is responsible for protecting the human body, starts attacking the protective sheath (myelin) that covers nerve fibers and disrupts communication between the brain and the rest of the body, eventually leading to permanent damage to the nerves [1].

MS affects approximately 2.3 million people globally and can be categorized based on if the disease relapses or whether there is an increased progression of neurological damage and disability from the onset of the disease. At this point, no cure exists for MS. However, treatments can help recover from attacks or modify the disease course and manage symptoms.


FDA Approval

On August 20th, Novartis’ Kesimpta® (ofatumumab, formerly OMB157), a B-cell therapy, got FDA approved as a subcutaneous injection to be used for treating relapsing forms of multiple sclerosis (RMS) in adults [2]. Research suggests that preserving neurological functions can be facilitated by early initiation of high-efficacy treatment, thus improving long-term effects in patients. Research suggests that preserving neurological functions can be facilitated by early initiation of high-efficacy treatment, thus improving long-term effects in patients.

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, commented, “This approval is wonderful news for patients with relapsing multiple sclerosis. In the key clinical studies, this breakthrough treatment produced a profound reduction in new brain lesions, reducing relapses and slowing underlying disease progression. 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” [2].

Bruce Bebo, Ph.D., Executive Vice President of Research at the National MS Society, said, “Multiple sclerosis (MS) is a complex disease, and response to disease-modifying treatment will vary among individuals. This makes it important to have a range of treatments available with different mechanisms of action and routes of administration. We are pleased to have an additional option approved for the treatment of relapsing forms of MS.”



Ofatumumab was first approved by the FDA in 2009 for treating chronic lymphocytic leukemia (CLL). After rigorous studies that spanned over a period of 10 years and over 2300 patients, Ofatumumab was rebranded and renamed as a therapy for RMS. Kesimpta is a B-cell therapy, a treatment which generally binds to and decreases the number of B-cells connected to MS.

In previous studies, Kesimpta has shown higher efficacy and a similar safety profile when compared with teriflunomide (Phase III ASCLEPIOS I and II studies), a first-choice drug for RMS patients. What makes Kesimpta so unique is the fact that it is the first B-cell therapy that can be self-administered once per month at home via the autoinjector pen (APLIOS study), which lowers the cost associated with visiting the hospital for dose administration.

Marie-France Tschudin, President, Novartis Pharmaceuticals, added, “At Novartis, we challenge treatment paradigms and strive to offer the best treatment choice for patients. When treating patients with RMS, Kesimpta is a meaningful treatment option that delivers both high efficacy and safety with the ability for patients to have more freedom in managing their disease. The development of Kesimpta is a great example of our commitment, knowledge, and understanding of multiple sclerosis, which enabled us to identify a targeted treatment that can significantly improve patient outcomes and experience”.

Kesimpta is expected to be available in the US in early September, while it awaits regulatory approval in Europe and anticipates acquiring it by 2021.


ASCLEPIOS I and II Studies

ASCLEPIOS I and II are identical Phase III double-blinded, randomized clinical trials that tested the safety and efficacy of Kesimpta in comparison to teriflunomide in adults with RMS. Around 1882 patients were enrolled across 350 sites, and 37 countries and the patients received the drug for flexible durations of up to 36 months. Kesimpta reduced the relapse rate in patients by around 51-59% in the two clinical trials.

Further, the drug also reduced the relative risk by 34.4%. Kesimpta further reduced Gd+ T1 lesions and newly formed lesions. Upper respiratory tract infection, headache, and local injection site reactions were the most commonly observed adverse reactions. Finally, Kesimpta may be able to halt new disease activity in RMS patients, as the drug showed no evidence of disease activity.



The APLIOS study is a 12-week Phase II, open-label study to determine the timeline of onset of B-cell depletion post the Kesimpta monthly injection in patients with RMS. B cell depletion was recorded over 12 weeks, and Gd+ lesions were counted at baseline and monthly for 3 months. Kesimpta was able to achieve B cell depletion and sustain it. Following all injections, 95% of patients had <10 B cells/µL. Finally, after 3 months, treatment with Kesimpta reduced the lesions by 94.1%.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Sanofi Advances in Multiple Sclerosis Market with Principia Acquisition Deal



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