- ALITHIOS Phase IIIb open-label extension study data based on ~3.5 years of exposure demonstrated that mean immunoglobulin G (IgG) levels in patients treated with Kesimpta remained stable, and there was no apparent association between IgG levels and the risk of serious infections1
- ALITHIOS Phase IIIb open-label extension study data also showed mean immunoglobulin M (IgM) levels declined over time but remained within the reference range for the majority of patients. The overall incidence of serious infections was low1
- Additional ALITHIOS data showed 94% (n=139) of COVID-19 cases were mild or moderate in severity in adults treated with the B-cell targeting therapy2
- Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in multiple sclerosis (MS)3
Basel, October 14, 2021 — Today, Novartis announced data demonstrating the safety of Kesimpta® (ofatumumab) over extended exposure (~3.5 years) in patients with relapsing forms of multiple sclerosis (RMS).1 These data—presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place virtually, October 13–15, 2021— further support Kesimpta as a potential first-choice treatment option for adults with active RMS, including newly diagnosed patients.1
“Antibodies, also known as immunoglobulins, function as part of the healthy immune system, and reduced serum immunoglobulin levels have been previously linked to an apparent increased risk of infection. We are therefore encouraged by the results demonstrating that these levels remained within the reference range for patients taking Kesimpta,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals. “Providing safe and well-tolerated treatments with superior efficacy is of the utmost importance to Novartis in our continued efforts to reimagine MS care and improve the lives of people living with MS.”
These data build on previous efficacy and safety findings including the Phase III ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority versus teriflunomide in significantly reducing the annualized relapse rate (ARR, primary endpoint), 3-month confirmed disability progression (CDP), and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions.3
This media update 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 media update, 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 media update 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 such as COVID-19; 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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- Wiendl H., de Seze J., Bar-Or A., et al. Effect of ofatumumab on serum immunoglobulin levels and infection risk in patients with relapsing multiple sclerosis over 3.5 years. ePoster presentation at Virtual ECTRIMS Congress; October 2021.
- Cross AH., Delgado S., Habek M., Habek M., et al. Outcomes of COVID-19 in patients with relapsing multiple sclerosis receiving ofatumumab: data from the ALITHIOS study and post marketing surveillance. ePoster presentation at Virtual ECTRIMS Congress; October 2021.
- Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2020;383(6):546-557.
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