- Kesimpta reduced the risk of disability progression independent of relapse activity (PIRA) by up to almost 60% vs first-line teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS) according to new post hoc data from the Phase III ASCLEPIOS trials, further supporting Kesimpta as a first-choice treatment option for adults with RMS1
- More than 50% of confirmed disability worsening events in newly diagnosed, treatment-naïve RMS patients were PIRA, an emerging endpoint used in MS trials to measure disability worsening independent of relapses, indicating that disease progression starts early1
- Emerging open-label extension study data from the ALITHIOS trial showed that with this targeted B-cell therapy, precisely delivered through subcutaneous administration, mean serum IgM/IgG levels remained within the reference ranges over a three-year period to December 20202
Basel, April 16, 2021 — Novartis announced today new post hoc data from the Phase III ASCLEPIOS trials showing Kesimpta® (ofatumumab) reduced the risk of disability progression independent of relapse activity (PIRA) at three and six months vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS)1. These data, to be presented at the American Academy of Neurology (AAN) Annual Meeting being held virtually on April 17-22, 2021, further support Kesimpta as a first-choice treatment option for adults with RMS.
“This PIRA analysis shows more than half of the disability worsening events experienced by patients with early RMS were occurring regardless of whether they experienced relapses,” said Jacqueline A. Nicholas, MD, MPH, System Chief Neuroimmunology & MS, OhioHealth MS Center, Riverside Methodist Hospital, Columbus, Ohio. “Kesimpta reduced this risk of progression by up to almost 60% versus teriflunomide, reinforcing the importance of early intervention with high-efficacy treatment to address underlying disease progression before irreversible damage occurs.”
“Evidence shows that progression occurs in people living with MS in the early stages of disease. This reinforces the need to treat early with a first-choice treatment like Kesimpta, which combines powerful efficacy with a favorable safety profile and can be self-administered at home,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. “We are dedicated to advancing the scientific understanding of underlying progression so that we can ultimately improve the quality of life for people living with this chronic disease.”
All abstracts will be published in the journal Neurology following the meeting.
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.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]
- Kappos L, Montalban X, Coyle P, et al. Ofatumumab reduces disability progression independent of relapse activity in patients with relapsing multiple sclerosis. ePoster presentation at Virtual AAN Meeting; April 2021.
- Cross AH, Delgado S, Habek M, et al. Characteristics and outcome of COVID-19 in patients with relapsing multiple sclerosis receiving ofatumumab. ePoster presentation at Virtual AAN Meeting; April 2021.
# # #
Novartis Media Relations
E-mail: [email protected]
|Antonio Ligi||Meghan O’Donnell|
|Novartis External Communications||Novartis Global Pharma Communications|
|+41 61 324 1374||+41 79 797 9102|
|[email protected]||[email protected]|
|Novartis US External Communications|
|+1 862 579 8456|
Novartis Investor Relations
Central Investor Relations Line: +41 61 324 7944
E-mail: [email protected]
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 778 5052|
|Thomas Hungerbuehler||+41 61 324 8425|
|Isabella Zinck||+41 61 324 7188|