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

Zhitong Finance App learned that on March 6, the China National Drug Administration Drug Evaluation Center (CDE) official website announced that the marketing application for the Class 1 new drug remibutinib tablets declared by Novartis (NVS.US) will be included in priority review for adult chronic spontaneous urticaria (CSU) patients who still have symptoms after treatment with H1 antihistamines. The listing application was previously accepted by the CDE on February 27 this year.

According to public information, remibutinib (remibrutinib) is a BTK inhibitor being developed by Novartis. The initial indication for this product was to treat chronic spontaneous urticaria. Phase 3 clinical studies on this indication have yielded positive results. Patients improved their CSU symptoms as early as one week after receiving remibutinib treatment, and continued until 52 weeks. It is worth mentioning that this is the first time Remibutinib has been declared for sale globally.

CSU refers to chronic urticaria that lasts for 6 weeks or more. The root cause of the disease is internal factors rather than exposure to allergens or external triggers, and is characterized by the sudden appearance of itchy lumps and/or deep tissue swelling (angioedema, which can occur on the face, throat, hands, and feet).

Remibrutinib is a highly selective covalent oral BTK inhibitor under development that blocks the BTK cascade reaction and inhibits histamine release that causes itchy air mass and swelling. When remiburutinib is used in combination with standard doses of antihistamines, it produces a “two-pronged” effect on both parts of the inflammatory pathway. For both parts of the inflammatory pathway, remiburutinib inhibits histamine release, and antihistamines inhibit histamine receptors, thereby reducing CSU symptoms.