Novartis Receives EU Approval for Kesimpta® (Ofatumumab): The First and Only Monthly At-Home Subcutaneous B-Cell Therapy for Relapsing Multiple Sclerosis

March 31, 2021 /Bio ValleyBIOON/ -- Novartis recently announced that the European Commission (EC) has approved Kesimpta (ofatumumab) for the treatment of adult patients with relapsing multiple sclerosis (RMS) who have active disease defined by clinical or imaging features.NovartisWorking closely with all stakeholders to ensure that eligible European patients can benefit from this therapy as soon as possible.

August 2020, United StatesFDAApproval of Kesimpta, as a subcutaneous injection, for the treatment of adult patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Kesimpta is a novel targeted B-cell therapy that demonstrates superior efficacy and comparable safety to Aubagio (teriflunomide), a first-line medication for multiple sclerosis (MS). It is poised to become the preferred treatment option for a broad population of patients with relapsing forms of MS (RMS). Aubagio, an oral MS drug developed by Sanofi, is a leading oral disease-modifying therapy (DMT) in the industry.

It is worth mentioning that,Kesimpta is the first and only targeted B-cell therapy that can be easily administered and managed at home, administered via the Sensoready auto-injector as a once-monthly subcutaneous injection, will become the preferred treatment regimen for patients with RMS.

Traditionally, B-cell binding/depleting agents for the treatment of multiple sclerosis (MS) have been administered primarily in hospitals or infusion centers, which increases healthcare system costs and imposes lifestyle burdens on some patients. Kesimpta is a highly effective B-cell therapy administered via once-monthly subcutaneous injection, enabling patients to self-administer treatment at home and avoid visits to hospitals or infusion centers, thereby addressing a significant unmet need among patients with relapsing forms of multiple sclerosis (RMS).

One of the goals of managing RMS is to preserve neurological function and slow the progression of disability. Although several disease-modifying therapies (DMTs) are available for the treatment of RMS, most patients with RMS still experience disease activity. Evidence suggests that initiating high-efficacy therapy early can improve long-term outcomes in patients with RMS.

NovartisHaseeb Ahmad, Global Head of Pharmaceutical Value and Access, stated: “Slowing the progression of disability is one of the primary goals in managing relapsing multiple sclerosis (RMS), with evidence indicating that early initiation of high-efficacy therapy can improve long-term outcomes. Furthermore, as RMS progresses, the associated increase in disability may substantially raise overall healthcare costs. With its robust efficacy and favorable safety profile, Kesimpta has the potential to become a preferred treatment option for improving the quality of life of patients with multiple sclerosis, while also offering broader value by reducing medical costs associated with infusion therapies. Kesimpta demonstrates our commitment to reimagining medicine and our ongoing dedication to helping improve the lives of patients affected by this disease.”

The European Commission approved Kesimpta based on the results of two pivotal Phase III ASCLEPIOS studies. Both studies met their primary endpoints, with data showing that compared to Aubagio, Kesimpta reduced the annualized relapse rate (ARR) by more than 50% and lowered the relative risk of 3-month confirmed disability progression (CDP) by over 30%. Furthermore, compared to Aubagio, Kesimpta significantly reduced gadolinium-enhancing T1 brain lesions and new or enlarging T2 lesions. The results of these two studies were published in The New England Journal of Medicine on August 6, 2020. An independent post hoc analysis indicated that Kesimpta may halt new disease activity in patients with relapsing multiple sclerosis (RMS), with nearly 90% of patients treated with Kesimpta showing no evidence of disease activity (NEDA-3) during the second year of treatment.

Ofatumumab is a fully human anti-CD20 monoclonal antibody that functions by binding to CD20 molecules on the surface of B cells, thereby inducing effective B-cell lysis and depletion. Ofatumumab was first approved in the United States in 2009FDAApproved and marketed under the brand name Arzerra for the treatment of chronic lymphocyticLeukemia(CLL), this drug requires high-dose intravenous infusion in a medical institution.

NovartisSubsequently, ofatumumab for the treatment of RMS was investigated in a new development program, as it is well known that B cells play a role inAutoimmunityplays a key role in the progression of demyelinating diseases (such as MS). The clinical development program for ofatumumab in RMS spanned 10 years and, as part of rigorous research, involved more than 2,300 patients worldwide, reflecting a broad patient population. Kesimpta works through a unique mechanism of action, and its treatment regimen (dosing) is specifically designed for RMS, playing a critical role in outcomes. This represents a different dosing schedule and route of administration compared to the previously approved indication for chronic lymphocytic leukemia (CLL).

As a next-generation B-cell depleting agent, Kesimpta offers faster B-cell depletion and favorable safety profiles that preserve immunity, along with the convenience of self-administration via once-monthly subcutaneous injection. Since its market launch, it is expected to challenge Roche’s rapidly growing CD20-targeted therapy Ocrevus (ocrelizumab), whose global sales increased by 24% in 2020, reaching CHF 4.326 billion.

Multiple Sclerosis (MS) impairs the normal function of the brain, optic nerves, and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide. The disease is typically classified into three types: Relapsing-Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS, generally defined by the overall accumulation of cognitive and physical changes and disability), and Primary Progressive Multiple Sclerosis (PPMS). Approximately 85% of patients initially present with the relapsing form of multiple sclerosis.

In this field,NovartisThe product portfolio also includes: Gilenya (fingolimod, an S1P modulator), Mayzent (siponimod, a next-generation S1P modulator), and Extavia (interferon beta-1b for subcutaneous injection). In addition, its Sandoz division markets Glatopa (glatiramer acetate, 20 mg/mL and 40 mg/mL) in the United States, which is a generic version of Teva’s blockbuster multiple sclerosis (MS) drug Copaxone. (Bioon.com)

Original source: Novartis receives EUapproval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis