- Data show ligelizumab binds to immunoglobulin E (IgE), a key driver of chronic spontaneous urticaria (CSU), with significantly higher affinity than current standard of care Xolair (omalizumab)1
- The study published in Nature Communications suggests ligelizumab has the potential to be more effective than Xolair in treating CSU
- Earlier Phase IIb study results show more patients are completely symptom-free from CSU with ligelizumab than Xolair2
- CSU is a distressing and unpredictable skin condition with many patients having uncontrolled symptoms3
Basel, January 09, 2020 – Novartis, a leader in immuno-dermatology, announced mechanistic study results showing ligelizumab is more effective at inhibiting the major pathogenic IgE/FcεRI pathway in chronic spontaneous urticaria (CSU), than current therapy Xolair® (omalizumab)1. Ligelizumab can bind to IgE with an 88-fold higher affinity than Xolair1. The data show ligelizumab and Xolair recognize and bind differently to IgE, with ligelizumab resulting in a significantly enhanced blockade of IgE/FcεRI signaling.
“This mechanistic research study is a great step forward in understanding how different anti-IgE treatments can have qualitatively and functionally distinct inhibition profiles”, said one of the investigators of the study, PD Dr. Alexander Eggel, University of Bern, Switzerland.
“We were recently encouraged by previous clinical study results showing more patients are completely symptom-free from CSU with ligelizumab than Xolair2,” said Eric Hughes, Global Development Unit Head for Immunology, Hepatology and Dermatology, Novartis. “This mechanistic study further supports those findings as we look to reimagine care to bring better treatment options for patients with CSU.”
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,” “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 healthcare 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 and economic conditions; safety, quality 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 in CSU
Advancing ligelizumab further strengthens the immuno-dermatology pipeline of Novartis. In the US, Novartis and Genentech, Inc. work together to develop and co-promote Xolair. Outside the US, Novartis markets Xolair and records all sales and related costs. Xolair, indicated as an add-on therapy for the treatment of CSU, is the only therapy recommended by the global guideline on chronic urticaria (CU) for patients unresponsive to antihistamines. Ligelizumab (QGE031) is currently being investigated in an ongoing Phase III clinical trial program that includes Phase III trials PEARL 1 and PEARL 2 that are globally recruiting more than 2,000 patients across 48 countries around the world.
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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.
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- Gasser P, et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab is different from omalizumab. Nat Commun 2020; 11:165.
- Maurer M, et al. Ligelizumab for chronic spontaneous urticaria. N Engl J Med 2019;381:1321–1332.
- Maurer M, et al. Unmet clinical needs in chronic spontaneous urticaria: A GA(2)LEN task force report. Allergy 2011; 66:317–330.
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