Novartis has reported positive results from the Phase III RemIND trial evaluating its oral BTK inhibitor, remibrutinib, for the treatment of chronic inducible urticaria (CIndU). The study met its primary endpoint across the three most common CIndU subtypes — symptomatic dermographism, cold urticaria and cholinergic urticaria — demonstrating a significantly higher rate of complete response compared to placebo at 12 weeks. If approved, remibrutinib would be the first targeted therapy for CIndU, a condition estimated to affect approximately 29 million people globally.

Novartis has already submitted a supplemental new drug application (sNDA) to US regulators for remibrutinib for symptomatic dermographism, the most prevalent CIndU subtype. The drug is already approved in China and the US for chronic spontaneous urticaria (CSU). CIndU is characterised by hives and swelling triggered by specific external stimuli like pressure, cold or heat, and patients currently have limited treatment options beyond antihistamines. The full data set from the RemIND trial will be submitted to global health authorities and presented at a future medical conference.

According to PharmCube's NextBiopharm® database, there exist four approved products globally in this therapeutic area, including Novartis' omalizumab, rilonacept and remibrutinib. Click here to request a free trial for NextBiopharm®.