New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies

• ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing multiple sclerosis (RMS) following switch to Kesimpta after breakthrough disease* on fingolimod or fumarate-based therapies¹
  
  
• Following switch to Kesimpta, over 90% of people with RMS showed no evidence of disease activity (NEDA-3) and low annualized relapse rates (ARR) were observed¹
  
  
• In the separate ALITHIOS open-label extension study, more than 90% of patients receiving first-line Kesimpta were progression-free for up to seven years, reinforcing benefit of introducing Kesimpta early²

EAST HANOVER, N.J., Sept. 24, 2025 /PRNewswire/ -- Novartis today announced new data from two Kesimpta^® (ofatumumab) studies in relapsing multiple sclerosis (RMS) that will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting in Barcelona, Spain, on September 24–26.

Data from the ARTIOS Phase IIIb, open-label, single-arm, prospective study showed that patients who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies had a substantial reduction in disease activity, as shown by a low annualized relapse rate (ARR, 0.06 over 96 weeks)¹. The data also showed an almost complete suppression of MRI activity and over 9 out of 10 participants achieving no evidence of disease activity (NEDA-3)¹. No new safety concerns were observed following the switch to Kesimpta, irrespective of the last prior disease modifying treatment (DMT)¹.

Lead investigator Dr. Riley Bove of the University of California, San Francisco, stated, "These findings add to the growing evidence on the efficacy and safety of ofatumumab after a switch from oral DMTs. Crucially, we observed robust disease control sustained over two years in patients with RMS who did not respond well to oral DMTs."

The separate ALITHIOS open-label extension study includes recently diagnosed (≤3 years) treatment-naïve (RDTN) people with RMS receiving first-line continuous Kesimpta². The study showed more than 90% achieved NEDA-3 at seven years². Long-term efficacy was measured by sustained low ARR and profound suppression of MRI activity as well as a favorable safety profile, with no new safety concerns, in both the overall population and RDTN patients^2,3.

"The long-term data from these studies underscore Kesimpta's ability to deliver sustained efficacy and a consistent safety profile for people with RMS," said Norman Putzki, M.D., Ph.D., Global Head Development, Neuroscience & Gene Therapy, Novartis. "These findings reinforce Kesimpta's position as a therapy that empowers patients to take early control of their disease."

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord⁴. MS, which affects nearly 3 million people worldwide⁵, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)⁶. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease⁴.

About Kesimpta^® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously^7-10. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional^7,8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen¹¹. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015¹². Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 92 countries worldwide with more than 150,000 patients treated as of August 2025^7,8,13.

Novartis in Neuroscience
At Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, neuroimmunology, neurodegeneration and neuromuscular/rare diseases.

KESIMPTA

Indication 

What is KESIMPTA (ofatumumab) injection?
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.

It is not known if KESIMPTA is safe or effective in children. 

Important Safety Information 

Who should not take KESIMPTA?
Do NOT take KESIMPTA if you: 

• Have an active hepatitis B virus (HBV) infection.
• Have had an allergic reaction to ofatumumab or life-threatening injection-related reaction to KESIMPTA. 

What is the most important information I should know about KESIMPTA?
KESIMPTA can cause serious side effects such as: 

• Infections. Serious infections, which can be life-threatening or cause death, can happen during treatment with KESIMPTA. If you have an active infection, your health care provider (HCP) should delay your treatment with KESIMPTA until your infection is gone. KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your HCP right away if you have any infections or get any symptoms including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches. 
• HBV reactivation. If you have ever had HBV infection, it may become active again during or after treatment with KESIMPTA (reactivation). If this happens, it may cause serious liver problems including liver failure or death. Before starting KESIMPTA, your HCP will do a blood test to check for HBV. They will also continue to monitor you during and after treatment with KESIMPTA for HBV. Tell your HCP right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes.
• Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your HCP right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory, which may lead to confusion and personality changes.
• Weakened immune system. KESIMPTA taken before or after other medicines that weaken the immune system could increase your risk of getting infections. 

Before you take KESIMPTA, tell your HCP about all your medical conditions, including if you: 

• Have or think you have an infection including HBV or PML. 
• Have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection. 
• Have a history of liver problems.
• Have had a recent vaccination or are scheduled to receive any vaccinations. 
  • You should receive any required 'live' or 'live-attenuated' vaccines at least 4 weeks before you start treatment with KESIMPTA. You should not receive 'live' or 'live-attenuated' vaccines while you are being treated with KESIMPTA and until your HCP tells you that your immune system is no longer weakened. 
  • Whenever possible, you should receive any 'non-live' vaccines at least 2 weeks before you start treatment with KESIMPTA. 
  • Talk to your HCP about vaccinations for your baby if you used KESIMPTA during your pregnancy. 
• Are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KESIMPTA will harm your unborn baby. Females who can become pregnant should use birth control (contraception) during treatment with KESIMPTA and for 6 months after your last treatment. Talk with your HCP about what birth control method is right for you during this time. 
• Are breastfeeding or plan to breastfeed. It is not known if KESIMPTA passes into your breast milk. Talk to your HCP about the best way to feed your baby if you take KESIMPTA. 

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

How should I use KESIMPTA?
See the detailed Instructions for Use that comes with KESIMPTA for information about how to prepare and inject a dose of KESIMPTA and how to properly throw away (dispose of) used KESIMPTA Sensoready® pens or prefilled syringes. 

• Use KESIMPTA exactly as your HCP tells you to use it.
• Your HCP will show you how to prepare and inject KESIMPTA the right way before you use it for the first time.
• Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with moles, scars, or stretch marks. 

KESIMPTA may cause serious side effects including: 

• Injection-related reactions. Injection-related reactions are a common side effect of KESIMPTA. Injecting KESIMPTA can cause injection-related reactions that can happen within 24 hours (1 day) following the first injections and with later injections. There are two kinds of reactions: 
  • At or near the injection site: redness of the skin, swelling, itching, and pain. Talk to your HCP if you have any of these signs and symptoms.
  • That may happen when certain substances are released in your body: fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness. Contact your HCP right away if you experience any of these signs and symptoms, especially if they become worse or you have new severe signs of reactions after subsequent injections. It could be a sign of an allergic reaction, which can be serious. 
• Low immunoglobulins. KESIMPTA may cause a decrease in some types of antibodies. Your HCP will do blood tests to check your blood immunoglobulin levels. 
• Liver damage. KESIMPTA may cause liver damage. Your HCP will do blood tests to check your liver before you start KESIMPTA and while you take KESIMPTA if needed. Tell your HCP right away if you have any symptoms of liver damage such as:
  • yellowing of the skin and eyes (jaundice) 
  • nausea 
  • vomiting 
  • unusual darkening of the urine 
  • feeling tired or weak 

The most common side effects of KESIMPTA include: 

• Upper respiratory tract infection, with symptoms such as sore throat and runny nose, and headache. 
• Headache. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information including Medication Guide.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.us and connect with us on LinkedIn US, X/Twitter US and Instagram.

References

1. Bove R, Langdon D, Boer I, et al. Ofatumumab Safety and Efficacy in People Living With Relapsing Multiple Sclerosis With Breakthrough Disease on Oral Fumarates or Fingolimod: ARTIOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
2. Bittner S, Hauser SL, Pardo G, et al. Continuous Ofatumumab Treatment Up to 7 Years Shows a Consistent Safety and Efficacy Profile in Recently Diagnosed Treatment-Naive People Living With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
3. Hauser SL, Bar-Or A, Cross AH, et al. Continuous Ofatumumab Treatment for Up to 7 Years Shows a Favourable Safety and Efficacy Profile in People With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
4. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317.
5. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977.
6. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/understanding-ms/what-is-ms/types-of-ms Accessed August 13, 2025.
7. Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.novartis.com/us-en/sites/novartis_us/files/kesimpta.pdf Accessed September 12, 2025.
8. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. February 2025. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf Accessed August 20, 2025.
9. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515.
10. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27–29, 2020; West Palm Beach, FL, US.
11. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14–17, 2016; London, UK.
12. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d Accessed August 13, 2025.
13. Novartis. Data on file.

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SOURCE Novartis Pharmaceuticals Corporation