Novartis receives Health Canada approval for (Pr)RHAPSIDO® (remibrutinib tablets) oral treatment for adults with CSU

• RHAPSIDO^® (remibrutinib tablets) is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ¹
• The phase III clinical trials REMIX-1 and REMIX-2 showed efficacy and a favorable safety profile of RHAPSIDO^® (remibrutinib tablets). ²

MONTREAL, July 27, 2026 /CNW/ -- Novartis Pharmaceuticals Canada Inc. ("Novartis Canada") is proud to announce that Health Canada has issued a Notice of Compliance (NOC) for RHAPSIDO^® (remibrutinib tablets) for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.¹ The decision is supported bythe phase III REMIX-1 and REMIX-2 double-blind, randomized, placebo-controlled studies.

CSU is characterized by itch, hives and/or angioedema persisting for more than 6 weeks without an identifiable cause.^2,3 CSU can place a significant physical, emotional, and social burden on patients, potentially leading to sleep disturbances, fatigue, pain, stigma, and profound impacts on mental well-being, relationships, and quality of life.³

"Every person with chronic spontaneous urticaria is different, so having more treatment options is important. A fast, convenient, needle-free treatment that can help with both hives and swelling could make a meaningful difference in my patients' daily lives," said Dr. Vipul Jain, Allergist and Clinical Immunologist. "This is exciting news for both patients and the clinicians who care for them."

"CSU patients often face uncertainty every day, never knowing when symptoms may flare or how they will affect their plans, work, or family life. Any advancement that expands treatment options for this community is welcome news and reinforces the importance of continuing to address unmet patient needs" said Dana Gies, Executive Director at Canadian Skin Patient Alliance (CSPA).

Research has shown that activation of Bruton tyrosine kinase (BTK) triggers the release of histamine and other proinflammatory mediators that contribute to the symptoms of CSU.^4,5,6 Phase III clinical trials support the efficacy of RHAPSIDO^® (remibrutinib tablets) to selectively inhibit BTK, resulting in improvements from baseline in Urticaria Activity Score (UAS7) at week 12.²

"This approval represents meaningful progress for Chronic Spontaneous Urticaria patients and reflects our ongoing commitment to bringing innovative medicines to those who need them most. We are proud to continue advancing immunology research and addressing patients' most pressing unmet needs" said Dimitri Gitas, Country President of Novartis Canada.

About RHAPSIDO^® (remibrutinib tablets)

RHAPSIDO^® (remibrutinib tablets) is an oral, highly selective Bruton tyrosine kinase (BTK) inhibitor that blocks BTK-mediated mast cell and basophil degranulation, preventing the release of histamine and other proinflammatory mediators that trigger CSU symptoms.² 

The phase III clinical trials REMIX-1 and REMIX-2 demonstrated that RHAPSIDO^® (remibrutinib tablets) 25 mg twice daily was superior to placebo in reducing UAS7 scores from baseline at week 12 in adult patients with CSU whose disease remained symptomatic despite treatment with H1 antihistamines.²

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 diseases. Our medicines reach nearly 300 million people worldwide.  

In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 500 people to serve the evolving needs of patients and the healthcare system and invests over $36 million in R&D yearly in the country. Reimagine medicine with us: Visit us at www.novartis.ca and connect with us on LinkedIn. 

References

	1.	RHAPSIDO^® (remibrutinib tablets) Product Monograph. Novartis Pharmaceuticals Canada Inc. 2026.
	2.	Giménez-Arnau, A. M., Szalewski, R., Hide, M., et al. (2026). Remibrutinib in chronic spontaneous urticaria: 52-week results from two phase 3 studies. Journal of Allergy and Clinical Immunology, 157(1), 143–154. https://doi.org/10.1016/j.jaci.2025.09.028
	3.	Weller, K., Winders, T., McCarthy, J., Raftery, T., Saraswat, P., Constantinescu, C., Balp, M. M., & Bernstein, J. A. (2025). Urticaria Voices: Real-World Experience of Patients Living with Chronic Spontaneous Urticaria. Dermatology and therapy, 15(3), 747–761. https://doi.org/10.1007/s13555-025 -01348-8
	4.	Johal, K. J., & Saini, S. S. (2020). Current and emerging treatments for chronic spontaneous urticaria. Annals of Allergy, Asthma & Immunology, 125(4), 380–387. https://doi.org/10.1016/j.anai.2020.07.017
	5.	Neys, S. F., Rip, J., Hendriks, R. W., & Corneth, O. B. (2021). Bruton's tyrosine kinase inhibition as an emerging therapy in systemic autoimmune disease. Drugs, 81(14), 1605–1626. https://doi.org/10.1007/s40265-021-01577-9
	6.	Dispenza, M. C., Regan, J. A., & Bochner, B. S. (2017). Potential applications of Bruton's tyrosine kinase inhibitors for the prevention of allergic reactions. Expert Review of Clinical Immunology, 13(10), 921–923. https://doi.org/10.1080/1744666X.2017.1372425

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis media contact: Florencia Casares, Head, Communications and Patient Advocacy, Phone: [phone], E-mail: [email protected]