BASEL (dpa-AFX) - 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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