#United States #Multiple Sclerosis #Novartis #East Hanover #Kesimpta

New Efficacy Data for Kesimpta® in Treating Relapsing Multiple Sclerosis

In a recent announcement, Novartis shared compelling data regarding the efficacy of their drug Kesimpta® (ofatumumab) for patients with relapsing multiple sclerosis (RMS). These insights arise from two significant studies that demonstrated the drug's effectiveness after patients transitioned from oral disease-modifying therapies (DMTs) such as fingolimod or fumarate-based treatments.

Key Findings from ARTIOS Study

The ARTIOS Phase IIIb trial provided encouraging results, showing substantial decreases in disease activity among participants who switched to Kesimpta® due to ongoing MS symptoms despite previous treatment. Over a monitoring period of 96 weeks, participants exhibited a notably low annualized relapse rate (ARR) of just 0.06. Furthermore, an impressive 90% of subjects achieved No Evidence of Disease Activity (NEDA-3), alongside significant MRI activity suppression, indicating a marked improvement in disease control.

Lead investigator Dr. Riley Bove from the University of California, San Francisco, commented on these promising results, emphasizing the strong and sustained disease control experienced by patients who previously had insufficient responses to oral DMTs. He stated, "These findings add to the growing body of evidence surrounding the safety and efficacy of ofatumumab after switching from oral treatments."

ALITHIOS Study: Long-Term Benefits

The separate ALITHIOS open-label extension study focused on recently diagnosed treatment-naïve individuals receiving first-line Kesimpta® treatment. This research further solidified the drug’s position as an effective remedy. With over 90% of participants achieving NEDA-3 over a seven-year period, the study underscored the benefits of initiating treatment with Kesimpta® early in the disease’s progression. Low ARR rates coupled with substantial MRI activity suppression highlighted the long-term efficacy and reliable safety profile of the treatment.

Dr. Norman Putzki, M.D., Ph.D., Global Head of Development in Neuroscience and Gene Therapy at Novartis, stated, "These studies emphasize Kesimpta's capability to provide sustained efficacy and a consistent safety profile for individuals with RMS. They reinforce the potential of Kesimpta as a therapy for empowering patients to take early control of their disease."

Understanding Multiple Sclerosis

Multiple sclerosis is a chronic inflammatory condition affecting nearly three million individuals globally. The disease manifests in various forms, including relapsing-remitting, secondary progressive, and primary progressive types. Patients suffering from RMS typically experience acute inflammatory attacks of worsening neurological function, leading to significant disabilities over time.

About Kesimpta®

Kesimpta® operates as a targeted, precisely dosed B-cell therapy that allows for self-administration through subcutaneous injection. It is designed as an anti-CD20 monoclonal antibody, and its therapeutic action focuses on depleting B-cells in lymph nodes crucial for managing MS. Following initial healthcare-guided doses, patients can manage their treatments with monthly self-injections.

With a history of over 150,000 patients treated across 92 countries, Kesimpta® continues to emerge as a beacon of hope for many living with RMS. Originally developed by Genmab, the rights for ofatumumab were transferred to Novartis from GlaxoSmithKline in December 2015.

As Novartis continues to advance in neuroscience treatment over the past 80 years, developing transformative therapies that improve patients’ lives remains their utmost mission. The promising results surrounding Kesimpta® illustrate a significant step forward in the fight against relapsing MS, providing patients hopeful prospects for controlling their disease effectively.