Novartis Reports P-III Studies (REMIX-1 & 2) Results of Remibrutinib for Chronic Spontaneous Urticaria
Shots:
- The P-III studies evaluating remibrutinib (25mg, BID) in 470 & 455 patients whose symptoms are inadequately controlled by H1-antihistamines. Enrolled patients continue to receive treatment up to 52wk. & will continue in a long-term extension trial
- Both studies meet their 1EPs & 2EPs i.e., rapid, clinical improvements across urticaria disease activity scores. Remibrutinib (BTK inhibitor) also showed a rapid improvement as early as 2wks. after treatment initiation, was well-tolerated with a favorable safety profile, incl. balanced liver function tests
- The results are expected to be submitted to global health authorities in 2024. If remibrutinib is approved, it will become the first of a new class of CSU treatment offering a simple & effective option for patients uncontrolled by H1-antihistamines
Ref: Novartis | Image: Novartis
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