Novartis AG has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of oral remibrutinib for the treatment of symptomatic dermographism, a type of chronic inducible urticaria (CIndU). The submission follows positive Phase III results demonstrating that remibrutinib met its primary endpoint in three types of CIndU. Full data will be submitted to health authorities globally in the coming months.

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