Health Canada has approved Novartis’ RHAPSIDO (remibrutinib tablets) for adults with chronic spontaneous urticaria who remain symptomatic despite treatment with H1 antihistamines. The oral, needle-free therapy is supported by the Phase III REMIX-1 and REMIX-2 studies, which showed efficacy and a favorable safety profile.
Chronic spontaneous urticaria, or CSU, is marked by itch, hives and/or angioedema lasting more than six weeks without an identifiable cause. Novartis said the condition can significantly affect patients physically, emotionally and socially, with consequences that may include sleep disruption, fatigue, pain, stigma and reduced quality of life.
The company said RHAPSIDO works by selectively inhibiting Bruton tyrosine kinase, a pathway linked to the release of histamine and other pro-inflammatory mediators that drive CSU symptoms. In the Phase III trials, the treatment improved Urticaria Activity Score 7 results at week 12 compared with baseline.
Novartis Canada Country President Dimitri Gitas said the approval represents meaningful progress for CSU patients and reflects the company’s commitment to innovative medicines and immunology research. Allergist and Clinical Immunologist Dr. Vipul Jain said a fast, convenient, needle-free treatment that can help with both hives and swelling could make a meaningful difference in patients’ daily lives.
Canadian Skin Patient Alliance Executive Director Dana Gies said CSU patients often live with uncertainty over when symptoms may flare and how they may affect work, family life and daily plans. She said any advancement that broadens treatment options is welcome and underscores the need to keep addressing unmet patient needs.
The approval gives Canadian adults with CSU another option after antihistamines, adding a new oral therapy to the treatment landscape.
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