A
A
A

诺华宣布Rhapsido®获得欧盟委员会批准用于治疗慢性自发性荨麻疹

·in 6 hours发布

  • Significant improvements as early as Week 1, favorable safety profile and no liver safety concerns in REMIX 1 & 2 studies of highly selective, oral BTKi1

  • Rhapsido recommended in 2026 International Urticaria Guideline for all patients who remain symptomatic after H1-antihistamine treatment2

  • CSU affects nearly 4 million people in Europe; more than 50% continue to experience debilitating symptoms after conventional antihistamine therapy3-5

 

Basel, April 27, 2026 – Novartis announced today that the European Commission (EC) approved Rhapsido® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any 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 received a positive opinion in February 2026 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is included in the 2026 International Guideline for the Definition, Classification, Diagnosis and Management 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,” said Patrick Horber, M.D., President, International, Novartis.

 

About Remibrutinib


Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of itchy hives (wheals) and swelling6-8. By reducing histamine release, Remibrutinib helps relieve the symptoms of chronic spontaneous urticaria (CSU)9,10. Remibrutinib is approved in the US,China and several other countries for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines. Remibrutinib has shown positive topline results in chronic inducible urticaria (CIndU) across the three most prevalent subtypes in the pivotal Phase III RemIND trial. It is also being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio11-15.

 

About REMIX-1 and REMIX-2


REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) 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, hives, and weekly urticaria activity at Week 12. Remibrutinib has a demonstrated safety profile that requires no lab monitoring. The most common adverse events (incidence ≥3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain15,16.

 

About chronic spontaneous urticaria (CSU)


CSU is a chronic skin condition affecting approximately 40 million people worldwide5,18, impacting nearly twice as many women than men8 and occurring most frequently between the ages of 20-40 years. It is characterized by the sudden appearance of itchy hives (wheals) and/or deep tissue swelling (angioedema), which can appear on the face, throat, hands, and feet8,19 and occur without exposure to any allergen or external trigger5,8,17. Symptoms last for 6 weeks or longer and cause significant physical and emotional distress. The majority of CSU patients suffer from sleep deprivation, and high rates of mental disorders, such as anxiety or depression, as well as decreased work productivity8.

 

About Novartis Immunology


At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.

 

About Novartis


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.

​

  1. Metz M, Giménez-Arnau A, Hide M, et al. Long-term efficacy and safety of remibrutinib in 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, Spain

  2. Zuberbier T et al. The International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. Allergy. 6 Feb 2026. doi:10.1111/all.70210.

  3. Fricke J, Ávila 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):423–432. doi:10.1111/all.14037

  4. Worldometer. Europe Population (2025). Available at: https://www.worldometers.info/population/europe/ [Last accessed February 2026]

  5. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy 2011; 66: 317-330.

  6. Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506.

  7. 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: 5102-5118.

  8. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565.

  9. Jain V, Giménez-Arnau A, Hayama K, et al. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol 2024; 153: 479-486.

  10. Patient. Antihistamines. Last updated 12 October 2022. Available from: https://patient.info/allergies-blood-immune/allergies/antihistamines [Last accessed: February 2026].

  11. 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: February 2026]

  12. 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: February 2026].

  13. 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: February 2026].

  14. 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: February 2026].

  15. 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 [Last accessed February, 2026].

  16. ClinicalTrials.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 [Last accessed February, 2026].

  17. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy 2022; 77: 734-766.

  18. The World Bank. Population, total. Available from: https://data.worldbank.org/indicator/SP.POP.TOTL [Last accessed: February 2026].

  19. AAAAI (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 [Last accessed: February 2026].

文章关键词： 诺华Rhapsido®慢性自发性荨麻疹
下载PDF
0
发布文章
0
关注人数