Remibrutinib could be new effective and fast-acting oral treatment option for chronic spontaneous urticaria: Phase 3 trials
Written By : Dr. Kamal Kant Kohli
Published On 2023-08-12 05:45 GMT | Update On 2023-08-12 11:15 GMT
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Switzerland: The phase 3 trials REMIX-1 and REMIX-2 have yielded positive top-line results, as announced by Novartis. Trials assessed remibrutinib 25 mg b.i.d., an inhibitor of Bruton’s tyrosine kinase (BTK), in people with a diagnosis of chronic spontaneous urticaria (CSU) and with symptoms not adequately managed through H1-antihistamines.
“These positive top-line results from the Phase III REMIX studies confirm that remibrutinib, a highly selective BTK inhibitor, has the potential to be a first-in-class, oral treatment for people living with CSU whose symptoms are refractory despite the use of antihistamines.” Shreeram Aradhye, MD, Novartis's President of Global Drug Development and Chief Medical Officer said in a statement.
The studies successfully met the primary goal of assessing the absolute change from baseline in the weekly urticaria activity score (UAS7) at 12 weeks, suggesting substantial improvements in disease activity that are both statistically significant and clinically meaningful. The trials are also set to continue till the 52-week mark.
In the study, remibrutinib also demonstrated rapid onset of action, as researchers observed an improvement in UAS7 occurring as early as 2 weeks in both the REMIX-1 and REMIX-2 trials.
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