Novartis Pharma AG

Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria (CSU)

• Remibrutinib, a highly selective oral BTKi, has potential to be first targeted therapy approved for CSU in Europe
  
  
• Improvements with remibrutinib observed as early as Week 1 in REMIX 1 & 2, with favorable safety profile including no liver safety concerns through Week 52¹
  
  
• CSU affects nearly 4 million people in Europe, with over 50% of patients remaining symptomatic despite H1-antihistamines^2-4

Basel, February 27, 2026 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib. The opinion supports its use as an oral treatment for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1‑antihistamine treatment.

“The introduction of remibrutinib represents a major advancement, providing clinicians with an oral Bruton’s tyrosine kinase inhibitor (BTKi) treatment, with improvements in symptoms observed as early as Week 1,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin. “CSU continues to impose a substantial unmet medical need, as many patients struggle to achieve adequate disease control with currently available therapies.”

The positive CHMP opinion is supported by results from the pivotal REMIX-1 and REMIX-2 Phase III trials. Remibrutinib showed improvements in itch and hives as early as Week 1, with benefits sustained through Week 52¹. Improvements in quality of life and sleep were also observed early in treatment ¹. Remibrutinib was well tolerated and demonstrated a favorable safety profile, including no liver safety concerns across both studies through Week 52¹.

“People living with CSU often endure years of frustration, and difficulty being taken seriously. For many, the unpredictable itch flare‑ups can make it hard to sleep, focus on daily responsibilities, or even perform their jobs at times,” said Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform (GAAPP). “The arrival of a new oral treatment option brings us one step closer to ensuring that every person has the opportunity to live fully again.”

“Today’s positive CHMP opinion is an important step towards addressing the significant unmet needs of adults living with CSU in Europe,” said Patrick Horber, M.D., President, International, Novartis. “We will continue to collaborate with regulatory authorities globally to make this important medicine, discovered and developed by Novartis, available to patients who need it most.”

Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months.

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 swelling^5-7. By reducing histamine release, remibrutinib helps relieve the symptoms of chronic spontaneous urticaria (CSU)^8,9. In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido^®. 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 portfolio^10-14.

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 (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 ≥3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain^14,15.

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 trigger^4,7,16. CSU affects approximately 40 million people worldwide^4,17. 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 feet^7,18. 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.

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.

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 “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “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 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’s 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.

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.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

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. 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 
3. Worldometer. Europe Population (2025). Available at: https://www.worldometers.info/population/europe/ [Last accessed February 2026] 
4. 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. 
5. 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. 
6. 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. 
7. 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. 
8. 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. 
9. Patient. Antihistamines. Last updated 12 October 2022. Available from: https://patient.info/allergies-blood-immune/allergies/antihistamines [Last accessed: February 2026]. 
10. 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]
11. 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].
12. 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].
13. 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].
14. 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]. 
15. 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].
16. 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. 
17. The World Bank. Population, total. Available from: https://data.worldbank.org/indicator/SP.POP.TOTL [Last accessed: February 2026]. 
18. 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].  

# # #