Novartis Remibrutinib First Therapy for Chronic Urticaria

Novartis reported positive Phase III results for remibrutinib (Rhapsido) across all three major subtypes of chronic inducible urticaria (CIndU), making it the first therapy to demonstrate statistically significant efficacy in each population within a single pivotal study program. CIndU affects an estimated 29 million people worldwide for whom no approved targeted treatment currently exists.

Novartis reported full data from the RemIND trial (NCT05976243) at the European Academy of Allergy and Clinical Immunology Congress, showing complete response rates at week 12 of 29.3% versus 14.0% for placebo in symptomatic dermographism (SD), 56.3% versus 14.6% in cold urticaria, and 29.3% versus 15.8% in cholinergic urticaria. Responses were observed as early as week 2 in two of the three subtypes, and the drug demonstrated a favorable safety profile with no observed liver safety concerns.

Trial data

RemIND is a global Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating remibrutinib 25 mg twice daily in adults with CIndU inadequately controlled by H1-antihistamines. The primary endpoint — the proportion of complete responders at week 12 assessed through subtype-specific provocation tests — was met across all three cohorts. The cold urticaria arm produced the most pronounced separation from placebo, with a complete response rate of 56.3% versus 14.6%, a difference of roughly 42 percentage points. The SD and cholinergic urticaria arms showed more modest but statistically significant separation of approximately 15 percentage points each. Cross-trial comparisons are limited, but for context, Celldex Therapeutics' (Nasdaq: CLDX) barzolvolimab, a KIT-targeting antibody in Phase II for CIndU, reported complete response rates of up to 53% in cold urticaria and 58% in SD at week 12 in a smaller Phase II study — though the populations and assessment methods differ. Safety was consistent with remibrutinib's established profile in chronic spontaneous urticaria (CSU), with tolerability acceptable and no hepatic safety signals identified.

Competitive context

Remibrutinib's position in CIndU is analytically distinct from its CSU franchise in one important respect: it is the only agent to have completed a Phase III trial in this indication, giving Novartis a clear regulatory head start. Novartis has already submitted a supplemental NDA to the US FDA seeking approval for the SD subtype, received EU approval for remibrutinib in CSU in April 2026, and plans additional CIndU filings globally through 2026. The most credible near-term competitor in CIndU is Celldex's barzolvolimab, which targets mast cells directly via KIT inhibition and has initiated a Phase III program (EMBARQ-ColdU and -SD) in cold urticaria and SD — though topline data are not expected until later. Palo Alto-based Evommune's EVO756, an oral MRGPRX2 antagonist, showed 30% complete response rates at four weeks in a 30-patient Phase II study in SD, but remains considerably earlier in development. Remibrutinib's oral, twice-daily formulation and the absence of required lab monitoring — features already established in its CSU label — provide practical differentiation versus injectable competitors. The CIndU data also reinforce the broader "pipeline-in-a-pill" thesis for remibrutinib, which Novartis is advancing in hidradenitis suppurativa, food allergy, and neuroscience indications, supporting the commercial rationale for the molecule beyond its already-approved CSU use.

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