On 30th of September, 2025, the Food and Drug Administration (FDA) announced that Remibrutinib has been approved for use in chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite receiving H1-antihistamine treatment.
Remibrutinib is being sold under the brand name "Rhapsido", which is given orally and a small molecule that works by inhibiting the Bruton's tyrosine kinase.
Why do we need this medication?
Urticaria is one of the most common dermatological diseases that we know today. The symptoms usually occur within 24 hours, but for those with the chronic disease, these symptoms can last for more than 6 weeks and reoccur for 1 to 5 years, or longer for patients with severe cases, for which the condition can affect the patients' mental and physical health, work and personal lives and their sleep pattern at some point. Therefore, the need for a medication for this disease has risen in the last several years.
CSU is also one of the most mysterious of dermatological conditions, as the exact cause is unknown, and patients often present the condition without identifiable triggers. Although antihistamines are the standard treatment, "over half of patients still have symptoms, even at higher doses," according to the Novartis news release. Injectable biologic therapies, including omalizumab (Xolair; Genentech, Novartis), are available for patients who do not respond to antihistamines, but less than 20% of eligible patients take them.
References:
- Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Accessed September 30, 2025. https://www.globenewswire.com/news-release/2025/09/30/3159065/0/en/Novartis-receives-FDA-approval-for-Rhapsido-remibrutinib-the-only-oral-targeted-BTKi-treatment-for-chronic-spontaneous-urticaria-CSU.html
- Maurer M, Weller K, Bindslev‑Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria: a GA²LEN task force report. Allergy. 2011;66(3):317‑330. doi:10.1111/j.1398-9995.2010.02496.x
- Dabija D, Tadi P, Danosos GN. Chronic urticaria. In: StatPearls [Internet]. StatPearls Publishing; 2025.
- Maurer M, Raap U, Staubach P, et al. Antihistamine-resistant chronic spontaneous urticaria: 1-year data from the AWARE study. Clin Exp Allergy. 2019;49:655–662. doi:10.1111/cea.13309