Press Release: Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta(R) in people with relapsing mult...

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Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta(R) 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(R) (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 P7.016

a Consistent Safety Profile and Delays Disability Monday,

Progression in People with Relapsing Multiple Sclerosis April 7

5:00 -- 6:00 PM PT

-------------------------------------------------------- ------------------------

Long-Term Ofatumumab Treatment Over 6 Years Did Not P8.017

Increase the Risk of Serious Infections Tuesday,

April 8

8:00 -- 9:00 AM PT

-------------------------------------------------------- ------------------------

Longer-Term (up to 6 Years) Efficacy and Safety of P11.003

Ofatumumab in People with Non-highly Active MS Early Wednesday,

in the Disease Course April 9

8:00 -- 9:00 AM PT

-------------------------------------------------------- ------------------------

Real-World Data on Ofatumumab as First-line Treatment P7.013

in Early RMS (AIOLOS Study) Monday,

April 7

5:00 -- 6:00 PM PT

-------------------------------------------------------- ------------------------

Pipeline Molecules

----------------------------------------------------------------------------------

Remibrutinib Exposure in Cerebrospinal Fluid: Insights P12.003

from a Study in Healthy Participants Wednesday,

April 9

11:45 AM -- 12:45 PM PT

-------------------------------------------------------- ------------------------

Efficacy and Safety of Iptacopan in Patients with P7.027

Generalized Myasthenia Gravis: Study Design Monday,

April 7

5:00 -- 6:00 PM PT

-------------------------------------------------------- ------------------------

Biomarkers

----------------------------------------------------------------------------------

Prognostic Value of Baseline Serum Neurofilament Light P5.009

Chain (sNfL) Levels in People with Relapsing Multiple Monday,

Sclerosis by Prior Treatment Status and DMT Type 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.

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(END) Dow Jones Newswires

March 25, 2025 02:15 ET (06:15 GMT)