Novartis Files sNDA for Rhapsido in Symptomatic Dermographism After Phase III RemIND Data

A supplemental NDA for a new indication of an already-approved BTK inhibitor is now under FDA review, and the RemIND Phase III dataset behind it carries direct implications for regulatory affairs teams tracking how CMC packages and labeling amendments are structured for indication expansions in 2026. Novartis presented the RemIND trial results at the EAACI Congress on June 12, showing remibrutinib (Rhapsido®) met primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes: symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria.

Complete response rates at week 12 were approximately twice those of placebo across all three subtypes. In SD, 29.3% of patients on remibrutinib 25 mg twice daily achieved complete response versus 14.0% on placebo; in cold urticaria, 56.3% versus 14.6%; in cholinergic urticaria, 29.3% versus 15.8%. Responses were observed as early as week 2 in two subtypes. The trial reported a favorable safety profile with no observed liver safety signals, a point of particular relevance given the hepatotoxicity scrutiny applied to BTK inhibitors across the class.

Rhapsido holds existing approvals in the U.S., EU, China, South Korea, and several other markets for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamines. The current sNDA submission targets the SD subtype specifically, with additional filings to global health authorities planned through the remainder of 2026. For regulatory affairs leads, the filing sequence matters: SD carries the largest patient share among CIndU subtypes and represents the clearest path to a first-in-class labeled indication, given that no approved targeted therapies currently exist for any CIndU subtype.

The unmet need is quantifiable. Global CIndU prevalence is estimated at 29 million patients, with more than 50% experiencing significant disease burden despite second-generation H1-antihistamine treatment. That treatment gap shapes the benefit-risk framing regulators will apply to the sNDA, and QA and manufacturing teams supporting the submission will need to ensure the existing 21 CFR Part 211 CMC documentation for remibrutinib is current and aligned with any process or specification changes since the original NDA approval.

The FDA review timeline for the SD sNDA will serve as a reference point for the subsequent global submissions Novartis has signaled for 2026.

Source: Novartis via GlobeNewswire, June 12, 2026.