Novartis: Phase III Data On Oral Remibrutinib Shows Long-Term Efficacy & Safety In Chronic Urticaria

(RTTNews) - Novartis (NVS) announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton's tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria or CSU.

In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early, which was sustained up to Week 52, in patients with CSU who remained symptomatic despite second-generation H1-antihistamine use.

The company noted that Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and sustained to 1 year (Week 52) .

The company said Remibrutinib demonstrated a favorable and consistent safety profile up to 1 year, including balanced liver function tests versus placebo.

Novartis plans to submit remibrutinib for approval in chronic spontaneous urticaria (CSU) to global health authorities starting in the second-half of 2024, and continues to investigate remibrutinib in multiple immune-mediated conditions.

Data reaffirmed the first-in-class potential of remibrutinib for the more than 50% of patients with CSU uncontrolled by H1-antihistamines who continue to live with painful and debilitating symptoms.

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