Novartis presents Rhapsido® (remibrutinib) data at AAAAI, showing potential beyond chronic spontaneous urticaria (CSU)

• 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:

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.

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