Important enhancements as early as Week 1, favorable security profile and no liver security considerations in REMIX 1 & 2 research of extremely selective, oral BTKi1Rhapsido really useful in 2026 Worldwide Urticaria Guideline for all sufferers who stay symptomatic after H1-antihistamine treatment2CSU impacts almost 4 million folks in Europe; greater than 50% proceed to expertise debilitating signs after standard antihistamine therapy3-5
Basel, April 27, 2026 – Novartis introduced at this time that the European Fee (EC) authorised Rhapsido® (remibrutinib) for power spontaneous urticaria (CSU) in grownup sufferers with insufficient response to H1-antihistamine remedy. Rhapsido is the primary oral focused remedy authorised for CSU, providing a singular method to CSU remedy in a capsule taken twice each day with none lab monitoring required1.
“CSU is a serious disease that causes debilitating symptoms, like itch and swelling, with unpredictable flares that greatly impact patients’ emotional wellbeing, sleep, and productivity,” says Prof. Dr med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin, Germany. “The approval of Rhapsido marks a major step forward, offering fast relief by blocking a key immune pathway, which may help a broad range of patients experience significant control of their disease.”
Rhapsido acquired a constructive opinion in February 2026 from the Committee for Medicinal Merchandise for Human Use (CHMP) of the European Medicines Company (EMA) and is included within the 2026 Worldwide Guideline for the Definition, Classification, Analysis and Administration of Urticaria2.
“Today’s approval represents an important advance for CSU patients, offering new hope for faster relief and better day to day disease control. Rhapsido is being developed for multiple immune-mediated conditions in addition to CSU— such as chronic inducible urticaria, food allergy, hidradenitis suppurativa—highlighting the broad potential of a targeted oral BTK pathway approach,” stated Patrick Horber, M.D., President, Worldwide, Novartis.
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About RemibrutinibRemibrutinib is a extremely selective, oral BTK inhibitor that blocks the BTK pathway concerned within the launch of histamine, a key driver of itchy hives (wheals) and swelling6-8. By lowering histamine launch, Remibrutinib helps relieve the signs of power spontaneous urticaria (CSU)9,10. Remibrutinib is authorised within the US,China and several other different international locations for the remedy of grownup sufferers with CSU who’ve an insufficient response to H1-antihistamines. Remibrutinib has proven constructive topline ends in power inducible urticaria (CIndU) throughout the three most prevalent subtypes within the pivotal Section III RemIND trial. It’s also being investigated in different immune-mediated circumstances, comparable to hidradenitis suppurativa (HS) and meals allergy, along with different indications within the firm’s Neuroscience portfolio11-15.
About REMIX-1 and REMIX-2REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) are two identically designed, international, multicenter, randomized, double-blind, parallel-group, placebo-controlled Section III trials, consisting of 925 sufferers who remained symptomatic on second-generation H1-antihistamines. Remibrutinib demonstrated superiority in change from baseline versus placebo in itch, hives, and weekly urticaria exercise at Week 12. Remibrutinib has a demonstrated security profile that requires no lab monitoring. The most typical antagonistic occasions (incidence ≥3%) had been nasal congestion, sore throat, and runny nostril (nasopharyngitis), bleeding, headache, nausea, and stomach pain15,16.
About power spontaneous urticaria (CSU)CSU is a power pores and skin situation affecting roughly 40 million folks worldwide5,18, impacting almost twice as many ladies than men8 and occurring most ceaselessly between the ages of 20-40 years. It’s characterised by the sudden look of itchy hives (wheals) and/or deep tissue swelling (angioedema), which might seem on the face, throat, palms, and feet8,19 and happen with out publicity to any allergen or exterior trigger5,8,17. Signs final for six weeks or longer and trigger important bodily and emotional misery. The vast majority of CSU sufferers endure from sleep deprivation, and excessive charges of psychological problems, comparable to anxiousness or melancholy, in addition to decreased work productivity8.
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About Novartis ImmunologyAt Novartis, we’re advancing daring science with the aim of bringing reduction and a renewed sense of hope to folks residing with autoimmune ailments. Constructing on our legacy of first-in-class innovation throughout rheumatology, dermatology and allergy, and a various industry-leading pipeline, we’re dedicated to shaping what’s subsequent in Immunology.
DisclaimerThis press launch incorporates forward-looking statements inside the which means of america Personal Securities Litigation Reform Act of 1995. Ahead-looking statements can typically be recognized by phrases comparable to “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or comparable phrases, or by categorical or implied discussions relating to potential advertising approvals, new indications or labeling for the investigational or authorised merchandise described on this press launch, or relating to potential future revenues from such merchandise. You shouldn’t place undue reliance on these statements. Such forward-looking statements are based mostly on our present beliefs and expectations relating to future occasions, and are topic to important recognized and unknown dangers and uncertainties. Ought to a number of of those dangers or uncertainties materialize, or ought to underlying assumptions show incorrect, precise outcomes could range materially from these set forth within the forward-looking statements. There may be no assure that the investigational or authorised merchandise described on this press launch shall be submitted or authorised on the market or for any further indications or labeling in any market, or at any explicit time. Nor can there be any assure that such merchandise shall be commercially profitable sooner or later. Specifically, our expectations relating to such merchandise may very well be affected by, amongst different issues, the uncertainties inherent in analysis and growth, together with medical trial outcomes and extra evaluation of present medical information; regulatory actions or delays or authorities regulation typically; international tendencies towards well being care value containment, together with authorities, payor and basic public pricing and reimbursement pressures and necessities for elevated pricing transparency; our skill to acquire or preserve proprietary mental property safety; the actual prescribing preferences of physicians and sufferers; basic political, financial and enterprise circumstances, together with the consequences of and efforts to mitigate pandemic ailments; security, high quality, information integrity or manufacturing points; potential or precise information safety and information privateness breaches, or disruptions of our data know-how programs, and different dangers and elements referred to in Novartis AG’s present Type 20-F on file with the US Securities and Alternate Fee. Novartis is offering the knowledge on this press launch as of this date and doesn’t undertake any obligation to replace any forward-looking statements contained on this press launch because of new data, future occasions or in any other case.
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References
Metz M, Giménez-Arnau A, Conceal M, et al. Lengthy-term efficacy and security of remibrutinib in sufferers with power spontaneous urticaria within the Section 3 REMIX-1 and REMIX-2 research. Offered as a late oral summary session on medical trials at EAACI 2024; Could 31-June 3, 2024; Valencia, Spain Zuberbier T et al. The Worldwide Guideline for the Definition, Classification, Analysis and Administration of Urticaria. Allergy. 6 Feb 2026. doi:10.1111/all.70210.Fricke J, Ávila G, Keller T, Weller Ok, Lau S, Maurer M, Zuberbier T, Keil T. Prevalence of power urticaria in youngsters and adults throughout the globe: Systematic evaluate with meta-analysis. Allergy. 2020;75(2):423–432. doi:10.1111/all.14037 Worldometer. Europe Inhabitants (2025). Out there at: https://www.worldometers.information/inhabitants/europe/ [Last accessed February 2026] Maurer M, Weller Ok, Bindslev-Jensen C, et al. Unmet medical wants in power spontaneous urticaria. A GA²LEN job pressure report. Allergy 2011; 66: 317-330. Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and security in power spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (remibrutinib), a potent and extremely selective covalent inhibitor of Bruton’s Tyrosine Kinase. J Med Chem 2020; 63: 5102-5118. Powell RJ, Leech SC, Until S, et al. BSACI guideline for the administration of power urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565. Jain V, Giménez-Arnau A, Hayama Ok, et al. Remibrutinib demonstrates favorable security profile and sustained efficacy in power spontaneous urticaria over 52 weeks. J Allergy Clin Immunol 2024; 153: 479-486. Affected person. Antihistamines. Final up to date 12 October 2022. Out there from: https://affected person.information/allergies-blood-immune/allergy symptoms/antihistamines [Last accessed: February 2026]. ClinicalTrials.gov. NCT03827798. Research of efficacy and security of investigational remedies in sufferers with average to extreme hidradenitis suppurativa. Out there from: https://clinicaltrials.gov/ct2/present/NCT03827798. [Last accessed: February 2026] ClinicalTrials.gov. NCT05432388. Research of efficacy, security and tolerability of remibrutinib in grownup contributors with an allergy to peanuts. Out there from: https://clinicaltrials.gov/research/NCT05432388 [Last accessed: February 2026]. ClinicalTrials.gov. NCT05147220. Efficacy and security of remibrutinib in comparison with teriflunomide in contributors with relapsing a number of sclerosis (RMS) (REMODEL-1). Out there from: https://clinicaltrials.gov/research/NCT05147220 [Last accessed: February 2026]. ClinicalTrials.gov. NCT05156281. Efficacy and security of remibrutinib in comparison with teriflunomide in contributors with relapsing a number of sclerosis (RMS) (REMODEL-2). Out there from: https://clinicaltrials.gov/research/NCT05156281 [Last accessed: February 2026]. ClinicalTrials.gov. NCT05030311. A Section 3 research of efficacy and security of remibrutinib within the remedy of CSU in adults inadequately managed by H1 antihistamines (REMIX-1). Out there from: https://clinicaltrials.gov/research/NCT05030311 [Last accessed February, 2026]. ClinicalTrials.gov. NCT05032157. A Section 3 research of efficacy and security of remibrutinib within the remedy of CSU in adults inadequately managed by H1- antihistamines (REMIX-2). Out there from: https://clinicaltrials.gov/research/NCT05032157 [Last accessed February, 2026]. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The worldwide EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, prognosis, and administration of urticaria. Allergy 2022; 77: 734-766. The World Financial institution. Inhabitants, complete. Out there from: https://information.worldbank.org/indicator/SP.POP.TOTL [Last accessed: February 2026]. AAAAI (American Academy of Allergy, Bronchial asthma & Immunology). Hives (urticaria) and angioedema overview. Out there from: https://www.aaaai.org/tools-for-the-public/conditions-library/allergy symptoms/hives-(urticaria)-and-angioedema-overview [Last accessed: February 2026].
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