Novartis's Remibrutinib Shows Rapid Improvement In Type Of Skin Disorder That Impacts 40M People

Novartis AG NVS announced topline results from the Phase 3 REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg twice daily in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. 

Affecting 40 million people worldwide, CSU is characterized by itchy hives (wheals) and/or deep tissue swelling (angioedema), which can occur on the face, throat, hands, and feet. Patients may experience burning, stinging, and soreness on the skin where hives occur.

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The Phase 3 studies met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, demonstrating clinically meaningful and statistically significant improvements in disease activity. 

The studies will continue until Week 52. 

Patients on remibrutinib saw rapid improvement as early as two weeks after treatment initiation.

Novartis will present the REMIX data at an upcoming medical meeting and submit it to global health authorities starting in 2024.

If approved, remibrutinib has the potential to become the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade, offering a simple and effective option for the 60% of patients uncontrolled by H1-antihistamines.

Price Action: NVS shares are up 0.15% at $103.20 premarket on the last check Wednesday.