Novartis Files sNDA After Phase 3 RemIND Remibrutinib Trial Success
Novartis reported pivotal Phase 3 RemIND trial of oral remibrutinib in chronic inducible urticaria met its primary endpoint at Week 12, delivering significantly higher complete response rates versus placebo across symptomatic dermographism, cold urticaria and cholinergic urticaria patients. The company has filed a supplemental NDA with the FDA seeking approval for remibrutinib in symptomatic dermographism.
1. Phase 3 RemIND Trial Results
Novartis’ pivotal Phase 3 RemIND trial evaluated oral remibrutinib in three prevalent forms of chronic inducible urticaria, meeting the primary endpoint at Week 12 with significantly higher complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic urticaria patients.
2. Supplemental NDA Filing
Following the positive topline data, Novartis submitted a supplemental New Drug Application to the FDA requesting approval of remibrutinib for symptomatic dermographism, building on its existing approval in chronic spontaneous urticaria.
3. Commercial Outlook
If approved, remibrutinib would become the first targeted therapy for chronic inducible urticaria, expanding Novartis’ immunology portfolio and addressing an unmet need in patients with pressure-, cold- and heat-triggered hives.