Novartis' Rhapsido Poised to Become the First Targeted Therapy for Chronic Inducible Urticaria

Novartis is making significant strides in dermatological care, announcing positive Phase 3 trial results for its oral BTK inhibitor, Rhapsido (remibrutinib). The pharmaceutical company is actively seeking U.S. FDA approval for what could soon become the first targeted therapy for chronic inducible urticaria (CIndU), addressing a major unmet medical need in the immunology space.

CIndU is a chronic and burdensome skin condition that affects an estimated 29 million people worldwide, representing roughly 0.5% of the global population. Unlike chronic spontaneous urticaria (CSU)—which has no specific, identifiable triggers—CIndU is characterized by severe hives and swelling provoked by physical stimuli. Currently, there are no approved targeted therapies for this condition, forcing many patients to continuously cycle through standard antihistamines without experiencing adequate relief.

In the global Phase 3 RemIND trial, Novartis enrolled 364 adults whose CIndU was inadequately controlled by H1-antihistamines. The study evaluated Rhapsido against a placebo and successfully met its primary endpoint across the three most prevalent forms of the condition: symptomatic dermographism (triggered by friction or light scratching), cold urticaria (triggered by cold temperatures), and cholinergic urticaria (triggered by body heat from exercise, strong emotions, or hot water). After 12 weeks of treatment, patients taking Rhapsido achieved significantly higher complete symptom response rates compared to the placebo group. Furthermore, the drug was well-tolerated and demonstrated a favorable safety profile with no liver safety concerns.

Following these robust findings, Novartis has submitted a supplemental New Drug Application (sNDA) to the FDA, targeting an initial approval for symptomatic dermographism, the most common subtype of CIndU. The company plans to share the complete dataset with global regulators in the coming months and will present findings at upcoming medical congresses.

Securing this approval would be a strategic victory for Novartis. While the twice-daily oral tablet was already approved in September for CSU, that market is highly crowded with formidable, injected biologic competitors like Roche’s Xolair and Sanofi and Regeneron’s Dupixent. By expanding into CIndU, Novartis is tapping into an untapped niche indication, effectively bypassing immediate competition from Dupixent in this specific patient population. If approved, Rhapsido could fundamentally transform the standard of care for millions suffering from trigger-based hives.

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🔖 Sources

Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU)

Novartis heads to FDA with Rhapsido after phase 3 win in untapped chronic hives subtype

Novartis' oral BTK drug moves the needle in CINDU

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Keywords: Targeted Therapy for Chronic Inducible Urticaria

Targeted Therapy for Chronic Inducible Urticaria

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