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25.03.2025 07:15:00

Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta® in people with relapsing multiple sclerosis

Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta® in people with relapsing multiple sclerosis

  • Long-term disability and safety data from ALITHIOS open-label extension study on continuous treatment with Kesimpta vs. later switch from teriflunomide in relapsing multiple sclerosis (RMS) patients to be presented

  • Additional presentations highlight the Novartis neuroscience pipeline, including remibrutinib for RMS and iptacopan for generalized myasthenia gravis

Basel, March 25, 2025 – Novartis will present data from studies across its neuroscience portfolio, including seven-year disability outcomes and safety data from the ALITHIOS open-label extension trial of Kesimpta® (ofatumumab) in people with relapsing multiple sclerosis (RMS), at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego from April 5-9, 2025. Additional data on Kesimpta and pipeline assets including remibrutinib and iptacopan will also be highlighted.

"We look forward to sharing several clinical and real-world studies on Kesimpta in people living with RMS as well as additional studies across our neuroscience portfolio,” said Norman Putzki, M.D., Ph.D., Development Unit Head, Neuroscience & Gene Therapy, Development, Novartis. "As always, we are excited to attend the AAN annual meeting and discuss the latest developments in neuroscience as we work to address some of the most pressing challenges for people living with neurological conditions.”

Data to be presented at AAN include:

Abstract Title        Abstract Number/ Presentation Details        
Kesimpta 
Continuous Ofatumumab Treatment Up to 7 Years Shows a Consistent Safety Profile and Delays Disability Progression in People with Relapsing Multiple Sclerosis P7.016
Monday,
April 7
5:00 – 6:00 PM PT
Long-Term Ofatumumab Treatment Over 6 Years Did Not Increase the Risk of Serious Infections P8.017
Tuesday,
April 8
8:00 – 9:00 AM PT
Longer-Term (up to 6 Years) Efficacy and Safety of Ofatumumab in People with Non-highly Active MS Early in the Disease Course P11.003
Wednesday,
April 9
8:00 – 9:00 AM PT
Real-World Data on Ofatumumab as First-line Treatment in Early RMS (AIOLOS Study) P7.013
Monday,
April 7
5:00 – 6:00 PM PT
Pipeline Molecules
Remibrutinib Exposure in Cerebrospinal Fluid: Insights from a Study in Healthy Participants P12.003
Wednesday,
April 9
11:45 AM – 12:45 PM PT
Efficacy and Safety of Iptacopan in Patients with Generalized Myasthenia Gravis: Study Design P7.027
Monday,
April 7
5:00 – 6:00 PM PT
Biomarkers
Prognostic Value of Baseline Serum Neurofilament Light Chain (sNfL) Levels in People with Relapsing Multiple Sclerosis by Prior Treatment Status and DMT Type P5.009
Monday,
April 7
8:00 – 9:00 AM PT
 NeofiLos – sNfL in Daily Clinical Routine P5.015
Monday,
April 7
8:00 – 9:00 AM PT

Product Information 
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products

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.

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.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com 
   
 

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com 

 
 

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