Novartis Advances Remibrutinib Toward FDA Approval in Chronic Inducible Urticaria | iPharmaCenter

Does Novartis remibrutinib work for chronic inducible urticaria? Yes, first Phase III success in 3 CIndU types

Oral remibrutinib hit primary endpoint vs. placebo at week 12 in RemIND trial, with complete responses in symptomatic dermographism, cold urticaria, and cholinergic urticaria.

Rhapsido CIndU approval status

Novartis seeks FDA approval for dermographism (most common form of CIndU).

Why This Matters

• First targeted therapy for CIndU, affecting ~29M adults worldwide

• Safe oral option - no liver concerns, well-tolerated profile

• Fills gap for patients failing H1-antihistamines (current standard)

Novartis has taken a step towards expanding remibrutinib's label, filing a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for symptomatic dermographism, common forms of chronic inducible urticaria (CIndU).

RemIND Trial: Phase III Breakthrough

The pivotal RemIND study delivered statistically superior complete response rates at Week 12 across CIndU's three most common subtypes:

• Symptomatic dermographism (pressure-induced hives)

• Cold urticaria (temperature-triggered)

• Cholinergic urticaria (exercise/heat-induced)

Remibrutinib, Novartis's oral BTK inhibitor, demonstrated a clean safety profile with no liver enzyme elevations - a key differentiator from earlier kinase inhibitors.

Clinical Context

CIndU impacts an estimated 29 million adults globally, yet lacks targeted therapies. Current care relies on escalating H1-antihistamine doses, often insufficient. Remibrutinib blocks the BTK pathway driving mast cell histamine release, addressing urticaria at its source.

Background of Rhapsido (remibrutinib)

Approved as Rhapsido in the U.S. and China for chronic spontaneous urticaria (CSU) failing antihistamines, remibrutinib advances in hidradenitis suppurativa and food allergy trials.

Market implications of remibrutinib

First oral targeted CIndU agent could capture marketshare in the under-served urticaria space.