Novartis kicks off BTK competition with TGA approval in chronic hives

The Therapeutic Goods Administration (TGA) has granted approval to Novartis Australia’s Rhapsido (remibrutinib), marking the first oral BTK inhibitor cleared for the treatment of chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine treatment.

CSU, also referred to as chronic hives, is a persistent inflammatory condition defined by recurring wheals, itch, and in some cases angioedema. The disorder can materially impair daily functioning, sleep quality, and emotional wellbeing. Symptoms are typically unpredictable, persisting for six weeks or longer and diagnosis may take up to 24 months.

“For many Australians living with chronic spontaneous urticaria, this is more than a skin condition – it’s a relentless, unpredictable disease that can disrupt sleep, affect mental wellbeing, and impact daily quality of life, said Sarah Emery, CEO, Allergy and Anaphylaxis Australia. “Despite current treatments, many individuals continue to live with persistent itch, pain and swelling. This milestone offers another option for the CSU community and reflects progress in addressing these gaps in care.”

Regulatory approval from the TGA is supported by findings from the REMIX-1 and REMIX-2 clinical trials. Across both studies, Rhapsido demonstrated statistically superior improvements compared with placebo in itch severity, hive burden and weekly urticaria activity scores at week 12. Extended follow-up data further indicated that nearly half of treated patients achieved complete resolution of itch and hives at 12 months.

“For a subset of patients, chronic spontaneous urticaria remains inadequately controlled despite existing therapies, reflecting the complex immunological mechanisms underlying the condition,” said Professor Connie Katelaris, Professor of Immunology & Allergy at the University of Western Sydney Western Sydney University. “Targeting key pathways involved in mast cell and basophil activation represents an evolution in the management approach. The availability of an oral therapy that acts on the BTK pathway may offer clinicians an additional option to consider when individualising treatment for appropriate patients with persistent symptoms.”

Competitive activity in the same therapeutic class is also emerging, with Sanofi’s BTK inhibitor Wayrilz (rilzabrutinib) currently being evaluated in global clinical trials for CSU. The therapy has not yet been submitted or approved for this indication in Australia.

“Patients experiencing chronic spontaneous urticaria often spend a long time trying different antihistamines before being referred on for specialist care,” explained A/Professor Erin McMeniman, Dermatologist, Princess Alexandra Hospital Department of Dermatology. “During that period, many are living with ongoing itch, hives and disruption to their daily lives. It can be hard to concentrate at work, and get to sleep at night. It is important to recognise when symptoms aren’t adequately controlled and consider treatment escalation. The TGA registration of Rhapsido is a welcome advancement providing another option for patients who continue to experience symptoms despite antihistamines.”

Nicole Johnston, Country Therapy Area Head Immunology at Novartis Australia and New Zealand, said “We are assessing the viability of a PBAC submission to achieve reimbursed access for patients. In the meantime, we will support access through private pathways, recognising the patient community unmet need.”

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