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01.09.2026 07:14:46
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Press Release: Novartis remibrutinib, a -2-
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com/ www.novartis.com and connect with us on https://www.linkedin.com/company/novartis/ LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$ Instagram.
References
1. Data on file
2. Metz M, Giménez-Arnau AM, Hide M, et al. Remibrutinib in chronic
spontaneous urticaria. N Engl J Med. 2025;392(10):984-994.
doi:10.1056/NEJMoa2408792
3. Giménez-Arnau AM, Szalewski R, Hide M, et al. Remibrutinib in
chronic spontaneous urticaria: 52-week results from two phase 3
studies. J Allergy Clin Immunol. 2026;157(1):143-154.
doi:10.1016/j.jaci.2025.09.028
4. Novartis. Novartis remibrutinib first therapy to achieve Phase III
primary endpoint in chronic inducible urticaria (CIndU). Novartis US.
Published February 18, 2026. Available
from: https://www.novartis.com/us-en/news/media-releases/novartis-remibru
tinib-first-therapy-achieve-phase-iii-primary-endpoint-chronic-inducible-
urticaria-cindu Last accessed: August 6, 2026
5. Ferreira HB, Neves B, Guerra IM, Moreira A, Melo T, Paiva A, Domingues
MR. An overview of lipidomic analysis in different human matrices of
multiple sclerosis. Mult Scler Relat Disord. 2020;44:102189.
doi:10.1016/j.msard.2020.102189
6. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis:
emerging epidemiological trends and redefining the clinical course.
Lancet Reg. Health Eur. 2024;44:100977.
7. National Multiple Sclerosis Society. Types of MS. Available
from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS Last
accessed: July 15, 2026
8. Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of
multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278-286.
doi:10.1212/WNL.0000000000000560
9. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (Remibrutinib),
a Potent and Highly Selective Covalent Inhibitor of Bruton's Tyrosine
Kinase. J Med Chem. 2020;63(10):5102-5118.
doi:10.1021/acs.jmedchem.9b01916
10. Kaul M, End P, Cabanski M, et al. Remibrutinib (LOU064): A selective
potent oral BTK inhibitor with promising clinical safety and
pharmacodynamics in a randomized phase I trial. Clin Transl Sci.
2021;14(5):1756-1768. doi:10.1111/cts.13005
11. Jain RW, Rayatpour A, Hagen K, et al. Investigations of remibrutinib in
models pertinent to multiple sclerosis. Neurotherapeutics.
2026;23(3):e00923. doi:10.1016/j.neurot.2026.e00923
12. Nuesslein-Hildesheim B, Ferrero E, Schmid C, et al. Remibrutinib (LOU064)
inhibits neuroinflammation driven by B cells and myeloid cells in
preclinical models of multiple sclerosis. J Neuroinflammation.
2023;20(1):194. Published 2023 Aug 26. doi:10.1186/s12974-023-02877-9
13. ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of
investigational treatments in patients with moderate to severe
hidradenitis suppurativa. Available
from: https://clinicaltrials.gov/ct2/show/NCT03827798. Last accessed:
July 2026
14. ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and
tolerability of remibrutinib in adult participants with an allergy to
peanuts. Available
from: https://clinicaltrials.gov/study/NCT05432388 Last accessed: July
2026
15. Novartis. Novartis receives FDA approval for Rhapsido(R) (remibrutinib),
the only oral, targeted BTKi treatment for chronic spontaneous urticaria
(CSU). News release. Novartis. September 30, 2025. Available from:
https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu
Last accessed: August 6, 2026
16. Novartis. Novartis Rhapsido(R) receives European Commission approval as
first oral targeted treatment for chronic spontaneous urticaria. News
release. Novartis. April 27, 2026. Available
from: https://www.novartis.com/news/media-releases/novartis-rhapsido-rece
ives-european-commission-approval-first-oral-targeted-treatment-chronic-s
pontaneous-urticaria Last accessed: August 6, 2026
17. ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib
compared to teriflunomide in participants with relapsing multiple
sclerosis (RMS) (REMODEL-1). Available from:
https://clinicaltrials.gov/study/NCT05147220 Last accessed: July 2026
18. ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib
compared to teriflunomide in participants with relapsing multiple
sclerosis (RMS) (REMODEL-2). Available from:
https://clinicaltrials.gov/study/NCT05156281 Last accessed: July 2026
19. Wiendl H, Airas L, Chitnis T, et al. Phase 3 REMODEL I/II Trials:
Efficacy, Safety, and Tolerability of Remibrutinib in Patients with
Relapsing Multiple Sclerosis. Mult Scler Relat Disord. 2023;80:105315.
doi:10.1016/j.msard.2023.105315
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Novartis Investor Relations
Central investor relations line:
+41 61 324 7944
E-mail: investor.relations@novartis.com
(END) Dow Jones Newswires
September 01, 2026 01:15 ET (05:15 GMT)
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