Novartis' BTK inhibitor in China to be reviewed under priority for treatment of urticaria.
1min read On March 6, the National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) website announced that novartis (NVS.US) had applied for priority review for its new drug Remibrutinib tablets, which is a first-class new drug. The drug is intended for adult patients with chronic spontaneous urticaria (CSU) who have symptoms after treatment with H1 antihistamines. The application was accepted by CDE on February 27 this year.According to public information, Remibrutinib is an in-development BTK inhibitor by Novartis. The drug's first indication is for the treatment of chronic spontaneous urticaria, and its Phase 3 clinical trial has achieved positive results. Patients' CSU symptoms improved within one week of receiving Remibrutinib treatment and lasted for 52 weeks. It is worth noting that this is the first time Remibrutinib has been submitted for approval globally.CSU refers to chronic urticaria lasting for more than 6 weeks, which is caused by intrinsic factors rather than exposure to allergens or external triggers. Its characteristics include sudden itchy windpuffs and/or deep tissue swelling (vascular edema, which can occur on the face, throat, hands, and feet).Remibrutinib is an in-development high-selective covalent oral BTK inhibitor that blocks the BTK cascade and inhibits histamine release, which causes itchy windpuffs and swelling. When Remibrutinib is used in combination with standard doses of antihistamines, it produces a "double-barreled" effect by inhibiting histamine release and histamine receptors, thus relieving CSU symptoms.
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