Novartis has received China National Medical Products Administration (NMPA) approval for its oral covalent BTK inhibitor remibrutinib in H1 antihistamine-inadequately controlled chronic spontaneous urticaria (CSU), based on the Phase III REMIX-1 and REMIX-2 trials showing significant improvement in urticaria activity score within one week and sustained through 52 weeks. The 25 mg twice-daily dosing demonstrated rapid itch and hive reduction in 925 patients, with median disease duration exceeding 24 months where over 50% remain symptomatic despite standard antihistamine therapy. The highly selective inhibitor targets the inactive BTK conformation, reducing mast cell and basophil activation with minimal systemic exposure and favourable safety profile.

CSU affects approximately 1% of the global population, with unpredictable flares and significant quality of life impact through sleep disturbance and psychological distress. Remibrutinib's mechanism addresses IgE- and IgG-mediated pathways upstream of current biologic therapies, offering an oral alternative to injectable options with under 20% treatment coverage in eligible patients. Novartis plans a market expansion in China following Europe and US approvals, positioning the drug as a first-in-class BTK inhibitor in allergic diseases, with potential applications across mast cell-mediated conditions including asthma and atopic dermatitis.

According to PharmCube's NextBiopharm® database, remibrutinib is under clinical development in eight other immunology indications. Click here to request a free trial for NextBiopharm®.