Novartis’ remibrutinib shows promising results in Phase III studies for chronic spontaneous urticaria

Novartis has revealed encouraging data from the Phase III REMIX-1 and REMIX-2 studies. The studies focused on remibrutinib, a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor, in treating chronic spontaneous urticaria (CSU) in patients inadequately controlled by H1-antihistamines. Remarkably, remibrutinib met all primary and secondary endpoints at Week 12, showcasing its potential in CSU management.

Significant Improvements in Urticaria Symptoms Noted

In the trials, remibrutinib demonstrated superiority over placebo in reducing weekly urticaria activity (UAS7), itch (ISS7), and hives (HSS7) from baseline at Week 12. Notably, a significant number of patients achieved well-controlled disease with remibrutinib, with about one-third experiencing complete absence of itch and hives at Week 12.

Expert Insights on the Impact of Remibrutinib

Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin Berlin, highlighted the potential transformative impact of remibrutinib for CSU patients. The treatment could provide relief as early as two weeks after antihistamines alone fail to control symptoms, significantly improving patients’ quality of life.

Remibrutinib’s Favorable Safety Profile in REMIX Studies

Pooled safety analyses from the REMIX studies showed that remibrutinib had a well-tolerated and favorable safety profile. The overall adverse event rates were comparable to placebo, including similar rates of infections and liver function test abnormalities. These findings suggest a promising safety aspect for remibrutinib in clinical use.

Novartis’ Commitment to Immuno-Dermatologic Disorders

Angelika Jahreis, Global Head of Development, Immunology at Novartis, expressed the company’s dedication to developing new therapies for patients with immuno-dermatologic disorders. Remibrutinib, as an oral BTK inhibitor, has shown significant symptom improvement early in the treatment, underscoring Novartis’ commitment to healthcare innovation.

Future Directions and Global Submission Plans for Remibrutinib

Participants in the REMIX-1 and REMIX-2 studies will continue receiving treatment up to Week 52, with an option for a long-term extension trial. Novartis plans to submit remibrutinib to global health authorities starting in 2024, positioning it as a potential new option for CSU patients.