Novartis' Remibrutinib, the First BTK Inhibitor for Chronic Spontaneous Urticaria, Files for Approval in China

Feb 27, 2025 14:03 CST Updated 14:03

Novartis

Drug Development and Manufacturing

On February 27, the CDE website showed that Novartis' Remibrutinib tablet (Remibrutinib) marketing application was accepted. Based on the clinical trial progress and Novartis press release, it is speculated that the indication for this application is Chronic Spontaneous Urticaria (CSU).This is the first domestically produced BTK inhibitor to seek regulatory approval for chronic urticaria in China.

Source: CDE Official Website

Rimebutinib is a covalent inhibitor targeting BTK, currently being developed for the treatment of urticaria, multiple sclerosis, hidradenitis suppurativa, myasthenia gravis, and other indications.

In May 2024, Novartis announced the Phase III clinical data of Remibrutinib for the treatment of chronic spontaneous urticaria. In the pivotal Phase III REMIX-1 and REMIX-2 studies, Remibrutinib demonstrated significant symptom improvement early in treatment, which persisted through week 52.

Consistent with the previous results at Week 12,Rimebutilin showed significant improvement compared to placebo., which was also confirmed at Week 24, including the weekly urticaria activity score.（UAS7）Weekly Itch Severity Score（ISS7）And Weekly Hive Severity Score（HSS7）。
At Week 24, patients receiving placebo switched to remibrutinib treatment;The efficacy of Remibrutinib was observed in the first week of switching and persisted until the end of the study.(Treatment 28 weeks).
At week 52, nearly half of the patients had no itching or hives at all.（UAS7=0）。

Insight database shows that currently, there are 5 BTK inhibitors approved for marketing in China, including Pirtobrutinib.(Eli Lilly), Orelabrutinib(Novartis China)、Zanubrutinib(BeiGene)、Acalabrutinib(AstraZeneca)and Ibrutinib(Johnson & Johnson), but no product has been approved yet for chronic urticaria.

Source: Insight Database

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