Novartis Rhapsido meets Phase 3 endpoints across three CIndU subtypes

Novartis has presented Phase 3 data from the RemIND trial at the European Academy of Allergy and Clinical Immunology Congress in Istanbul, showing that Rhapsido (remibrutinib) met its primary endpoint in all three of the most common chronic inducible urticaria subtypes. The company says this is the first global Phase 3 trial to demonstrate efficacy across these subtypes, which together affect an estimated 29 million people worldwide.

The trial assessed the proportion of patients achieving a complete response at week 12, using standardised provocation tests specific to each subtype. In symptomatic dermographism, 29.3% of patients on remibrutinib achieved a complete response compared with 14.0% on placebo. The gap was wider in cold urticaria, where 56.3% of the remibrutinib group responded versus 14.6% on placebo. In cholinergic urticaria, the figures were 29.3% and 15.8% respectively. Responses were observed as early as week 2 in two of the three subtypes. Novartis reported a favourable safety profile and said no liver safety concerns were identified.

Regulatory pathway

Novartis has already submitted a supplemental New Drug Application to the FDA seeking approval of Rhapsido specifically for the symptomatic dermographism subtype and has indicated that further filings to regulators globally will follow during 2026. Remibrutinib is already approved in the United States, European Union, China, South Korea and several other markets for chronic spontaneous urticaria in adults who have not responded adequately to H1-antihistamines.

Prof. Martin Metz, Deputy Director at the Institute of Allergology, Charité-Universitätsmedizin Berlin, noted that CIndU patients currently have no approved targeted options and that everyday triggers such as pressure, heat, cold or sunlight can provoke itchy wheals. "The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need," he said.

Rhapsido is a highly selective oral BTK inhibitor. It works by blocking the BTK pathway involved in histamine release, the principal driver of wheal formation and swelling in urticaria. The same mechanism underpins the drug's approved use in chronic spontaneous urticaria, and Novartis argues that the RemIND data are consistent with that established efficacy profile.

Market context

The chronic urticaria market has seen sustained interest from the pharmaceutical industry, but CIndU has historically sat in the shadow of chronic spontaneous urticaria, where Novartis's own omalizumab-containing franchise and other biologics have set a commercial benchmark. If the FDA approves the sNDA for symptomatic dermographism, Rhapsido would represent the first targeted, oral therapy in CIndU, a position that could command significant pricing latitude given the absence of competition.

More broadly, BTK inhibition is an increasingly crowded mechanism in haematology, but its application in allergic and immune-mediated skin disease remains less contested. Novartis is also investigating remibrutinib in hidradenitis suppurativa, food allergy and relapsing multiple sclerosis, suggesting a strategic intent to broaden the asset well beyond its current dermatology approvals. The FDA review timeline for the CIndU sNDA has not been disclosed, and investors will be watching for a PDUFA date alongside the full RemIND dataset, which is expected to be published in a peer-reviewed journal following the EAACI presentation.