- Novartis Canada has secured Health Canada approval for Rhapsido (remibrutinib) to treat adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. The approval is backed by data from the Phase III REMIX-1 and REMIX-2 trials.
- Rhapsido is an oral, BTK inhibitor that targets the underlying inflammatory pathway driving CSU. In the Phase III studies, it significantly improved Urticaria Activity Score (UAS7) at Week 12 while demonstrating a favourable safety profile.
- CSU is marked by persistent itching, hives, and/or angioedema lasting more than six weeks without an identifiable cause, often affecting sleep, mental well-being, work, relationships, and overall quality of life.
- Novartis says the approval expands treatment options for CSU patients, with clinicians highlighting the value of a fast, convenient, needle-free oral therapy that can help manage both hives and swelling.
Takeaways:
Rhapsido gives Canadian clinicians a first-in-class, oral BTK inhibitor option for CSU patients who are still symptomatic on H1 antihistamines, adding a targeted, needle‑free therapy that improves disease activity while fitting into everyday prescribing workflows.
Source: CA Newswire
