Novartis’ Rhapsido® Achieves Phase III Success in Three CIndU Subtypes, sNDA Filed
NVS•Novartis’ Phase III RemIND trial of Rhapsido® (remibrutinib) met primary endpoints across three predominant CIndU subtypes, showing higher complete response rates by Week 12 and responses as early as Week 2. The company has filed a supplemental NDA to US FDA for symptomatic dermographism and plans global submissions through 2026, expanding the drug’s targeted indications.
1. Phase III RemIND Trial Success
Novartis’ RemIND trial evaluated remibrutinib in symptomatic dermographism, cold urticaria and cholinergic urticaria, meeting primary endpoints across all three subtypes. Complete response rates were higher at Week 12, with notable early efficacy observed by Week 2 in two subgroups.
2. Supplemental NDA and Global Filing Plans
Novartis submitted a supplemental New Drug Application to the US FDA seeking approval specifically for symptomatic dermographism. The company expects to file additional regulatory submissions globally through 2026, targeting broader chronic inducible urticaria indications.
3. Potential Commercial and Patient Impact
If approved, Rhapsido could become the first targeted therapy for chronic inducible urticaria, addressing an unmet need for patients unresponsive to second-generation H1-antihistamines and potentially driving significant market opportunities for Novartis.
