Novarti's Rhapsido

Expanding the Future of Immunology Treatments:

Global pharmaceutical leader Novartis has presented new clinical findings for Rhapsido (remibrutinib) at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The research highlights the therapy’s growing potential not only for chronic spontaneous urticaria (CSU) but also for additional immune-mediated conditions, including food allergies.

The presentations reinforce the company’s commitment to developing innovative therapies for patients with difficult-to-treat allergic and inflammatory diseases. According to the company, several new analyses and clinical insights are being shared during the scientific meeting in Philadelphia.

New Evidence from Phase III CSU Studies:

One of the key highlights of the presentation includes new analyses from the REMIX-1 and REMIX-2 Phase III clinical trials, which evaluated the effectiveness of remibrutinib in patients suffering from chronic spontaneous urticaria. The findings demonstrate improved disease control and early symptom relief among participants treated with the therapy.

CSU is a chronic skin condition characterized by recurring hives, swelling, and severe itching that can significantly affect quality of life. Many patients continue to experience symptoms even after taking antihistamines, creating a strong demand for new treatment options.

Remibrutinib works by targeting Bruton's tyrosine kinase (BTK), a protein involved in immune cell activation and the release of histamine and inflammatory mediators that cause allergic reactions. By blocking this pathway, the drug helps reduce the underlying immune activity responsible for CSU symptoms.

Potential Breakthrough in Food Allergy Treatment:

Beyond urticaria, Novartis is also presenting Phase II clinical data exploring remibrutinib as a treatment for IgE-mediated peanut allergy. The study results, which will be featured in an oral presentation at the conference, evaluate both the safety and effectiveness of the therapy in patients with food allergies.

Encouraged by early findings, the company is planning to launch a Phase III program for food allergies in the second half of 2026. If successful, the therapy could represent a significant advancement for patients who currently have limited treatment options beyond strict allergen avoidance.

Food allergies remain a major global health concern, particularly among children and young adults. A convenient oral therapy capable of addressing the immune response behind allergic reactions could dramatically improve disease management and patient quality of life.

Growing Clinical Development Across Multiple Diseases:

Novartis continues to expand the development program for remibrutinib beyond CSU and food allergies. The drug is currently being studied in other immune-mediated conditions such as chronic inducible urticaria (CIndU) and hidradenitis suppurativa. Regulatory reviews for the CSU indication are also underway in several major healthcare markets, including the European Union and Japan, indicating the company’s broader global commercialization strategy.  In addition, the company has reported progress in late-stage trials for chronic inducible urticaria, further reinforcing the drug’s potential role as a targeted therapy for multiple allergic diseases.

Expert Perspective from Novartis:

According to Angelika Jahreis, Global Head of Immunology Development at Novartis, the emerging data strengthen confidence in remibrutinib as a promising oral therapy for allergic and immune-mediated conditions. The findings complement the drug’s recent regulatory milestones and highlight its broader therapeutic potential across several diseases.

The company emphasized that expanding treatment options for patients with limited alternatives remains a key priority as it continues to advance its immunology pipeline.

The Importance of Rhapsido in Modern Allergy Care:

Rhapsido represents a new class of targeted therapies designed to address the underlying immune mechanisms that trigger allergic symptoms. Unlike traditional antihistamines, BTK inhibitors such as remibrutinib intervene earlier in the allergic cascade by preventing immune cells from releasing histamine.

The drug also offers practical advantages, including oral dosing and the potential for long-term disease control, making it an appealing option for both patients and physicians managing chronic allergic disorders.

Conclusion:

The latest data presented by Novartis at the AAAAI Annual Meeting underline the growing importance of remibrutinib in the evolving landscape of immunology treatments. With promising results in chronic spontaneous urticaria and expanding research into food allergies and other immune-driven diseases, the therapy could play a significant role in addressing major unmet medical needs.

As Novartis continues advancing clinical trials and regulatory efforts worldwide, the progress of Rhapsido signals a broader shift toward targeted, mechanism-based therapies capable of transforming care for millions of patients living with allergic and inflammatory conditions.

Source – PR Newswire


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