Novartis Presents Rhapsido® (Remibrutinib) Data At AAAAI, Showing Potential Beyond Chronic Spontaneous Urticaria (CSU)

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• Analyses from REMIX-1 & -2 studies on CSU disease control and early symptom relief will be presented
  
• Phase II data evaluating safety and efficacy results of remibrutinib for treatment of peanut allergy to be featured in an oral session
  
• Phase III program in food allergy (FA) planned for H2 2026

Basel, February 23, 2026 – Novartis will present data from five key abstracts evaluating the highly selective oral Bruton's tyrosine kinase inhibitor (BTKi) Rhapsido^® (remibrutinib) in chronic spontaneous urticaria (CSU) and as an investigational therapy for peanut allergy at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, PA, from February 27 to March 2, 2026. These presentations provide more evidence on the use of Rhapsido in CSU, as well as its potential in other indications and highlight Novartis commitment to addressing unmet needs in patients with immune-mediated diseases.
New analyses on the impact of Rhapsido on disease control and early symptom relief from the Phase III REMIX-1 and REMIX-2 trials in CSU will be presented. Additionally, the first presentation of Phase II FA data for remibrutinib, focusing on IgE‐mediated peanut allergy, will be featured in an oral session. Plans are in progress to begin the Phase III program in FA in 2026.
“These food allergy (FA) data further strengthen the evidence supporting remibrutinib as a novel, well-tolerated, oral option for patients with allergic and immune-mediated diseases, complementing the recent FDA approval in chronic spontaneous urticaria (CSU) and underscoring its broader therapeutic potential,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. "Our priority is advancing therapies for patients who have few alternatives and expanding the reach of innovative medicines to transform care across multiple, high-need disease areas."
Regulatory reviews for remibrutinib for the treatment of CSU are underway in several regions, including the European Union and Japan.
In addition to FA, remibrutinib is in clinical development for chronic inducible urticaria (CIndU) and hidradenitis suppurativa (HS). FDA submission for remibrutinib in symptomatic dermographism, the most prevalent type of CIndU, was completed in Q4 2025. Additionally, positive topline results were announced for the remaining two arms of the CIndU Phase III RemIND trial. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented at upcoming medical congresses.
Abstracts accepted by AAAAI include:

Abstract Title	Abstract Number/Presentation Details
Efficacy and safety of remibrutinib, a Bruton's tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergy	Abstract #563 Oral Presentation Saturday, February 28 2:45-2:55 PM EST
Remibrutinib Decreases Urticaria Disease Activity Leading To Improved Disease Control: An Analysis From The REMIX-1/-2 studies	Abstract #822 Poster Sunday, March 1 3:30-5:00 PM EST
Remibrutinib Provides Fast Symptom Relief Within the First Week of Treatment in Chronic Spontaneous Urticaria, as Measured by Daily Urticaria Activity Score: Pooled REMIX-1/-2 Studies	Abstract #039 Poster Friday, February 27 2:45-3:45 PM EST
Patients with Chronic Spontaneous Urticaria (CSU) in the US (United States): Health Care Resource Utilization (HCRU) by Level of Disease Control	Abstract #021 Poster Friday, February 27 2:45-3:45 PM EST
A Novel Panel of Autoantibodies May Assist In The Molecular Diagnosis of CSU	Abstract #022 Poster Friday, February 27 2:45-3:45 PM EST

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