Mar 02, 2022
  • Multiple Sclerosis Journal has published data from the ALITHIOS open-label extension study which provide a robust picture of the continuous safety data for Kesimpta, showing it was well tolerated in ~2000 patients with up to 3.5 years exposure with no new safety risks identified1
  • Immunoglobulin G (IgG) levels remained stable in patients treated up to 3.5 years and mean immunoglobulin M (IgM) levels decreased yet remained above the lower limit of normal in most patients treated with Kesimpta1
  • Lower serum immunoglobulin (Ig) levels, which have been observed in anti-CD20 therapies, have been linked to an apparent increased risk of infection2; while immunoglobulin data with Kesimpta showed no association with risk of serious infections1
  • No opportunistic infections were identified and observed COVID-19 infections showed no evidence of an increase in incidence or severe outcomes in Kesimpta-treated patients1
  • 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 MS1

Basel, March 2, 2022 — Today, Novartis announced that new data from the ALITHIOS open-label extension study was published in the peer-reviewed Multiple Sclerosis Journal. The data showed that with up to 3.5 years of treatment with Kesimpta® (ofatumumab), no incidences of opportunistic infections were reported, and observed COVID-19 infections showed no evidence of an increase in incidence or severe outcomes in adults with relapsing forms of multiple sclerosis (RMS)1. Mean immunoglobulin G (IgG) levels remained stable and immunoglobulin M (IgM) levels remained above the lower limit of normal in most patients. The overall incidence of serious infections was low and no new safety risks were identified. This study, which included 1,969 RMS patients, provides a robust picture of the continuous safety data for Kesimpta1.

“The cumulative safety data suggest that treatment with Kesimpta over an extended period of time is well tolerated in adults with RMS and support the long-term use of Kesimpta in all RMS patients, including early MS patients1,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals. “While low serum immunoglobulin observed with anti-CD20 therapies have historically been linked with an apparent risk of serious infection, immunoglobulin data seen with Kesimpta over extended exposure showed that mean Ig levels remained within reference ranges with a low overall incidence of serious infection, including COVID-19. These data give confidence to people living with MS and their prescribing physicians, and further support Kesimpta as a potential first-choice treatment option for RMS.”

About Kesimpta® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously3,4. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion5. 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 spleen6. Once-monthly dosing of Kesimpta also allows faster repletion of B-cells and offers more flexibility7. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20158.

About ALITHIOS study
The ALITHIOS study is an ongoing open-label, single-arm, multi-center Phase IIIb study evaluating the long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS who have participated in a Novartis ofatumumab clinical MS study. The primary endpoint is the number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidality outcomes. Secondary endpoints include number of relapse rates per year, 3- and 6-month CDW, 6-, 12- and 24-month confirmed disability improvement and improvement until end of study. This study includes a vaccination sub-study investigating the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with RMS9.

Disclaimer
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.

About Novartis
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 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at
https://www.novartis.com.

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References

  1. Hauser S., Anne C., Winthrop K., et al. Safety experience with extended exposure to ofatumumab in patients with relapsing forms of multiple sclerosis. Multiple Sclerosis Journal (March 2022). https://doi.org/10.1177/13524585221079731
  2. Wiendl H, de Seze J, Correale J, et al. Effect of Ofatumumab on Serum Immunoglobulin Levels and Infection Risk in Patients With Relapsing Multiple Sclerosis Over 3.5 Years: 37th Congress of ECTRIMS, October 13-15, 2021.
  3. Kesimpta Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020.
  4. 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: ACTRIMS; February 2020; West Palm Beach, FL.
  5. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presentation at: ECTRIMS; September 2016; London, UK.
  6. 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: ECTRIMS; September 2016; London, UK.
  7. Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-cell recovery time following discontinuation of anti-CD20 therapies. ePoster presentation at: ECTRIMS; October 2017; Paris, FR.
  8. Genmab Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Accessed August 12, 2020. https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d
  9. U.S. National Library of Medicine. Long-term safety, tolerability and effectiveness study of ofatumumab in patients with relapsing MS. Accessed August 20, 2020. https://clinicaltrials.gov/ct2/show/NCT03650114

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