Novartis Receives Positive CHMP Opinion for Kesimpta (Ofatumumab): First At-Home, Once-Monthly Subcutaneous B-Cell Therapy for Relapsing Multiple Sclerosis

January 30, 2021/BioonBIOON/--Novartis(Novartis) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Kesimpta (ofatumumab) for the treatment of adult patients with relapsing multiple sclerosis (RMS) who have active disease defined by clinical or imaging features. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is expected to issue a final decision within two months.

August 2020, United StatesFDAApproved Kesimpta, as a subcutaneous injection, for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. On January 25, 2021, Health Canada approved Kesimpta for the treatment of relapsing-remitting multiple sclerosis (RRMS).

Kesimpta is a novel B-cell-targeted therapy that demonstrates superior efficacy and a comparable safety profile 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 B-cell therapy that can be easily administered and managed at home, delivered via the Sensoready autoinjector pen as a once-monthly subcutaneous injection.

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.

NovartisMarie France Tschudin, President of Pharmaceuticals, stated: “The positive opinion from the CHMP underscores Kesimpta’s potential to offer a new treatment option for patients with relapsing multiple sclerosis (RMS) in Europe, combining robust efficacy with a favorable safety profile and the convenience of self-administration at home. By eliminating the need for visits to infusion centers, Kesimpta not only reduces the burden on patients but also alleviates pressure on physicians and healthcare systems. Kesimpta exemplifies our commitment to reimagining medicines for the multiple sclerosis community, and we will work closely with regulatory authorities to ensure timely access to this therapy for people with multiple sclerosis across Europe.”

The CHMP’s positive opinion is based on the results of two pivotal Phase III ASCLEPIOS studies. Both studies met their primary endpoints, with data showing that, compared with 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 more than 30%. Furthermore, compared with 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 suggests that Kesimpta may halt new disease activity in patients with 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, marketed under the brand name Arzerra, for the treatment of chronic lymphocyticLeukemia(CLL), this drug requires high-dose intravenous infusion in a healthcare facility.

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 development of demyelinating diseases (such as MS). In RMS, the clinical development program for ofatumumab 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 (administration) 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 the advantageous safety profile of rapid B-cell depletion while preserving immunity, along with the convenience of self-administration via once-monthly subcutaneous injection. Since its market launch, the drug is poised to challenge Roche’s rapidly growing CD20-targeted therapy, Ocrevus (ocrelizumab), whose global sales surged by 57% in 2019 to reach an impressive CHF 3.708 billion.

Multiple Sclerosis (MS) impairs the normal functioning 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 relapsing forms of multiple sclerosis.

In this field,NovartisThe product portfolio 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 drug Copaxone. (Bioon.com)

Original Source: Novartis receives positive CHMP opinion for Kesimpta?* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis