Novartis : Phase III Studies Of Remibrutinib In Chronic Spontaneous Urticaria Meet Main Goal

(RTTNews) - Novartis (NVS) announced positive data from the Phase III REMIX-1 and REMIX-2 studies investigating remibrutinib in people with chronic spontaneous urticaria or CSU whose symptoms are inadequately controlled by H1-antihistamines. In the studies, remibrutinib met all primary and secondary endpoints at Week 12.

Remibrutinib is a highly selective, oral Bruton's tyrosine kinase (BTK) inhibitor.

Remibrutinib demonstrated superiority in change from baseline vs placebo in weekly urticaria activity (UAS7), itch (ISS7) and hives (HSS7) at Week 12. Significantly more patients achieved well-controlled disease with remibrutinib vs placebo, as early as Week 2 which was sustained at Week 12, and about one third of patients achieved complete absence of itch and hives at Week 12.

In pooled safety analyses of the REMIX studies, remibrutinib demonstrated a well-tolerated and favorable safety profile, with overall adverse event rates that were comparable to placebo (64.0% in remibrutinib vs 64.7% in placebo), including infections (32.8% in remibrutinib vs 34.0% in placebo) and liver function test abnormalities. Liver transaminase elevations were balanced across both treatment groups (remibrutinib and placebo), asymptomatic, transient and reversible. None of the serious adverse events were considered related to study medication by investigators.

Patients currently enrolled in REMIX-1 and REMIX-2 will continue to receive treatment up to Week 52 and will have the opportunity to continue in a long-term extension trial. Novartis intends to submit remibrutinib to global health authorities starting in 2024.

For More Such Health News, visit rttnews.com