Novartis AG Sponsored ADR (NVS.US) BTK inhibitors are expected to be included in priority review in China for the treatment of urticaria.

On March 6th, the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) announced that the market application for the class 1 new drug Remibrutinib tablets sponsored by Novartis AG Sponsored ADR (NVS.US) is expected to be included in the priority review. It is suitable for adult patients with chronic spontaneous urticaria (CSU) who still have symptoms after treatment with H1 antihistamines. This market application was accepted by CDE on February 27th this year. Public information shows that Remibrutinib is a BTK inhibitor under development by Novartis AG Sponsored ADR, and the initial indication of this product is for the treatment of chronic spontaneous urticaria. Phase 3 clinical studies targeting this indication have achieved positive results, with patients showing improvement in CSU symptoms as early as one week after receiving Remibrutinib treatment, which continued for up to 52 weeks. It is worth mentioning that this is the first time that Remibrutinib has applied for market approval globally. CSU refers to chronic urticaria lasting for 6 weeks or longer, and the fundamental cause of this disease is intrinsic factors rather than exposure to allergens or external triggers. It is characterized by the sudden appearance of itchy wheals and/or deep tissue swelling (angioedema, which can occur on the face, throat, hands, and feet). Remibrutinib is an investigational highly selective covalent oral BTK inhibitor that can block the BTK cascade reaction and inhibit histamine release that leads to itchy wheals and swelling. When used in combination with standard doses of antihistamines, Remibrutinib produces a "two-pronged" effect on the inflammatory pathway, with Remibrutinib inhibiting histamine release and antihistamines inhibiting histamine receptors, thereby alleviating CSU symptoms.