BASEL (dpa-AFX) - Novartis AG (NVS) on Thursday presented data from the Phase III RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress, highlighting the efficacy and safety of Rhapsido in chronic inducible urticaria (CIndU).
The RemIND trial met its primary endpoints across the three most common CIndU subtypes- cold urticaria, cholinergic urticaria, and symptomatic dermographism, making Rhapsido the first treatment to demonstrate efficacy in a Phase III trial for the condition.
The study evaluated the efficacy, safety and tolerability of Rhapsido in adults with CIndU whose symptoms were inadequately controlled by H1-antihistamines.
Rhapsido achieved statistically significant and clinically meaningful symptom control in about twice as many patients as placebo. The treatment showed a favorable safety profile, with no liver safety concerns observed.
Chronic inducible urticaria is a form of chronic hives in which triggers such as pressure, heat, cold or sunlight can cause itchy wheals.
Rhapsido is currently under review by the U.S. Food and Drug Administration for the symptomatic dermographism subtype of CIndU, with additional regulatory submissions planned globally in 2026.
The drug is already approved in the United States, European Union, China, South Korea and several other countries for adults with chronic spontaneous urticaria who have an inadequate response to H1-antihistamines.
Novartis shares closed Thursday's trading at $153.92, up 3.92%.
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