REMIX-1 (NCT05030311<\/a>) and REMIX-2 (NCT05032157<\/a>) are two identically designed, global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III trials, consisting of 925 patients who remained symptomatic on second-generation H1-antihistamines. Remibrutinib demonstrated superiority in change from baseline versus placebo in itch (ISS7), hives (HSS7), and weekly urticaria activity (UAS7) at Week 12. Remibrutinib has a demonstrated safety profile that requires no lab monitoring. The most common adverse events (incidence \u22653%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain14,15.<\/p>\n
About chronic spontaneous urticaria (CSU)
CSU is the medical term for chronic hives that last for 6 weeks or longer, where the underlying cause is internal rather than exposure to any allergen or external trigger4,7,16. CSU affects approximately 40 million people worldwide4,17. It is characterized by the sudden appearance of itchy hives (wheals) and\/or deep tissue swelling (angioedema), which can occur on the face, throat, hands, and feet7,18. CSU affects all ages but occurs most frequently between the ages of 20-40 years, with women affected nearly twice as often as men7. CSU causes significant emotional distress, with the majority of patients suffering from sleep deprivation, and high rates of mental disorders, such as anxiety or depression, as well as decreased work productivity7. <\/p>\n
About Novartis Immunology
At Novartis,\u00a0we\u2019re\u00a0advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases.\u00a0Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline,\u00a0we\u2019re\u00a0committed to shaping\u00a0what\u2019s\u00a0next in Immunology. <\/p>\n
Disclaimer
This press release 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 \u201cpotential,\u201d \u201ccan,\u201d \u201cwill,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cwould,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201clook forward,\u201d \u201cbelieve,\u201d \u201ccommitted,\u201d \u201cinvestigational,\u201d \u201cpipeline,\u201d \u201claunch,\u201d 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 press release, 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 press release 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; 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\u2019s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.<\/p>\n
About Novartis\u00a0
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people\u2019s 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.<\/p>\n
Reimagine medicine with us: Visit us at\u00a0https:\/\/www.novartis.com<\/a> and connect with us on LinkedIn<\/a>, Facebook<\/a>, X\/Twitter<\/a> and Instagram<\/a>.<\/p>\n References<\/p>\n Metz M,\u00a0Gim\u00e9nez-Arnau\u00a0A,\u00a0Hide\u00a0M, et al.\u00a0Long-term\u00a0efficacy\u00a0and safety of\u00a0remibrutinib\u00a0in patients with chronic spontaneous urticaria in the Phase 3 REMIX-1 and REMIX-2 studies. Presented as a late oral abstract session on clinical trials at EAACI 2024; May 31-June 3, 2024; Valencia, SpainFricke J, \u00c1vila G, Keller T, Weller K, Lau S, Maurer M, Zuberbier T, Keil T. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020;75(2):423\u2013432. doi:10.1111\/all.14037\u00a0Worldometer. Europe Population (2025). Available at: https:\/\/www.worldometers.info\/population\/europe\/<\/a>\u00a0[Last accessed February 2026]\u00a0Maurer M, Weller K,\u00a0Bindslev-Jensen C, et al.\u00a0Unmet clinical needs in chronic spontaneous urticaria. A GA\u00b2LEN task force report. Allergy 2011; 66: 317-330.\u00a0Maurer M, Berger W,\u00a0Gim\u00e9nez-Arnau\u00a0A, et al.\u00a0Remibrutinib, a novel BTK inhibitor,\u00a0demonstrates\u00a0promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506.\u00a0Angst D,\u00a0Gessier\u00a0F,\u00a0Janser\u00a0P, et al.\u00a0Discovery of LOU064 (remibrutinib), a potent and highly selective covalent inhibitor of Bruton’s Tyrosine Kinase. J Med Chem 2020; 63: 5102-5118.\u00a0Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565.\u00a0Jain V, Gim\u00e9nez-Arnau A, Hayama K, et al.\u00a0Remibrutinib\u00a0demonstrates favorable safety\u00a0profile\u00a0and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol 2024; 153: 479-486.\u00a0Patient. Antihistamines. Last updated 12 October 2022. Available from: https:\/\/patient.info\/allergies-blood-immune\/allergies\/antihistamines<\/a>\u00a0[Last accessed: February 2026].\u00a0ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from:\u00a0https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03827798<\/a>. [Last accessed: February 2026]ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from:\u00a0https:\/\/clinicaltrials.gov\/study\/NCT05432388<\/a>\u00a0[Last accessed: February 2026].ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from:\u00a0https:\/\/clinicaltrials.gov\/study\/NCT05147220<\/a> [Last accessed: February 2026].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<\/a>\u00a0[Last accessed: February 2026].ClinicalTrials.gov. NCT05030311. A Phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1 antihistamines (REMIX-1). Available from: https:\/\/clinicaltrials.gov\/study\/NCT05030311<\/a>\u00a0[Last accessed February, 2026].\u00a0ClinicalTrials.gov. NCT05032157. A Phase 3 study of efficacy and safety of remibrutinib in the treatment of CSU in adults inadequately controlled by H1- antihistamines (REMIX-2). Available from: https:\/\/clinicaltrials.gov\/study\/NCT05032157<\/a>\u00a0[Last accessed February, 2026].Zuberbier T, Abdul\u00a0Latiff\u00a0AH,\u00a0Abuzakouk\u00a0M, et al.\u00a0The international EAACI\/GA\u00b2LEN\/EuroGuiDerm\/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy 2022; 77: 734-766.\u00a0The World Bank. Population, total. Available from: https:\/\/data.worldbank.org\/indicator\/SP.POP.TOTL<\/a>\u00a0[Last accessed: February 2026].\u00a0AAAAI (American Academy of Allergy, Asthma & Immunology). Hives (urticaria) and angioedema overview. Available from: https:\/\/www.aaaai.org\/tools-for-the-public\/conditions-library\/allergies\/hives-(urticaria)-and-angioedema-overview<\/a> [Last accessed: February 2026]. \u00a0 <\/p>\n # # #<\/p>\n![\"\"](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/02\/1772219172_997_Novartis-Pharma-AG.png\"\/)