Novartis Submits sNDA for Remibrutinib in Symptomatic Dermographism

Novartis has submitted a supplemental new drug application to the U.S. Food and Drug Administration for remibrutinib in symptomatic dermographism, following positive Phase III RemIND trial results in chronic inducible urticaria (CIndU).

The global, randomised, double-blind, placebo-controlled study evaluated oral remibrutinib in adults with CIndU inadequately controlled by H1-antihistamines. The primary endpoint—complete response at week 12 based on provocation testing—was met across the three most common CIndU subtypes: cold urticaria, cholinergic urticaria and symptomatic dermographism, with higher response rates than placebo.

Remibrutinib, a selective Bruton’s tyrosine kinase inhibitor, reduces histamine release and related symptoms such as hives and swelling. The therapy is already approved in the US and China for chronic spontaneous urticaria. Novartis plans further regulatory submissions globally and additional data presentations. Recently, the company also reported positive Phase III results for Vanrafia in IgA nephropathy.

26-02-2026