Novartis Rhapsido® (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU) In Phase III RemIN...

What happened

Novartis reported that the U.S. Food and Drug Administration (FDA) approved Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. The company frames this as an expansion of Rhapsido’s approved use beyond chronic spontaneous urticaria (CSU) to the most prevalent form of chronic inducible urticaria (CIndU). The approval is described as based on data from the SD cohort of the Phase III RemIND clinical trial. (Issuer claim)

Sources: S1

Key clinical evidence cited

Novartis cites the RemIND SD cohort results, reporting that at Week 12 significantly more patients treated with Rhapsido versus placebo achieved complete response from hives, and that responses were observed as early as Week 2. The company also reports that in trials up to Week 24, Rhapsido demonstrated a consistent safety profile in SD and CSU and that no routine laboratory monitoring is required. These statements are presented by Novartis as the basis for FDA approval. (Issuer claim; trial phase and endpoint reported by issuer)

Sources: S1

Why the company highlights this

Novartis emphasizes that Rhapsido is now the only prescription treatment with approved uses in both CSU and SD when antihistamines alone do not control symptoms, and positions the approval as expanding the role of BTK inhibition across immune-mediated diseases. The company also notes ongoing studies of remibrutinib in other conditions including hidradenitis suppurativa, food allergy, and multiple sclerosis. (Issuer claims about indication landscape and ongoing development)

Sources: S1

What remains uncertain

• All clinical efficacy, safety, and indication statements in this draft come from the Novartis press release (S1) and reflect the company’s presentation of Phase III RemIND data; we do not have independent verification or access to full trial datasets, regulatory documents, or labeling text beyond S1.
• The press release references trial results “up to Week 24” and cites specific Week 12 comparisons; details on patient population size, full statistical analysis plans, secondary endpoints, and long-term safety outcomes are not provided in the supplied source.