Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today’s episode.

In this episode of Skinfluenced: The Skin Podcast, we review the FDA’s September 30, 2025 approval of remibrutinib (Rhapsido, Novartis), the first oral BTK inhibitor indicated for chronic spontaneous urticaria (CSU). We’ll walk through the press releases, clinical trial data, and recent publications highlighting its efficacy, safety, and potential impact on treatment pathways for CSU.

Link to Source(s):

The American Journal of Managed Care (AJMC). FDA Approves Remibrutinib for Chronic Spontaneous Urticaria. Published September 30, 2025. Accessed October 1, 2025. https://www.ajmc.com/view/fda-approves-remibrutinib-for-chronic-spontaneous-urticaria

BioSpace. Novartis Secures First FDA Approval of Oral BTK Inhibitor for Chronic Hives. Published September 30, 2025. Accessed October 1, 2025. https://www.biospace.com/fda/novartis-secures-first-fda-approval-of-oral-btk-inhibitor-for-chronic-hives

ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of Remibrutinib in Participants With Chronic Spontaneous Urticaria (NCT05030311). Updated 2025. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT05030311

ClinicalTrials.gov. A Study of Remibrutinib in Chronic Spontaneous Urticaria (NCT05032157). Updated 2025. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT05032157

Novartis. Novartis Receives FDA Approval for Rhapsido (Remibrutinib), the Only Oral Targeted BTKi Treatment for Chronic Spontaneous Urticaria (CSU). Published September 30, 2025. Accessed October 1, 2025. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu

Practical Dermatology. FDA Approves Remibrutinib for Adults With CSU. Published September 30, 2025. Accessed October 1, 2025. https://practicaldermatology.com/news/fda-approves-remibrutinib-for-adults-with-csu/2483590/

Reuters. US FDA Approves Novartis Drug for Skin Disease. Published September 30, 2025. Accessed October 1, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-novartis-drug-skin-disease-2025-09-30/

ScienceDirect. Remibrutinib in Chronic Spontaneous Urticaria: Results From Clinical Trials. Published 2022. Accessed October 1, 2025. https://www.sciencedirect.com/science/article/pii/S0091674922011812

The Derm Digest. Breaking News: The U.S. FDA Approves Remibrutinib (Rhapsido, Novartis) for CSU. Published September 30, 2025. Accessed October 1, 2025. https://thedermdigest.com/breaking-news-the-u-s-fda-approves-remibrutinib-rhapsido-novartis-for-csu/?utm_source=Klaviyo&utm_medium=campaign&_kx=LStbfMDiK_dFORiyt1p_kkItQ6IXDv9wQWWp60o95yV8qS2-9Wbebg-OUZpTxSvC.TYhhHR

Taylor & Francis Online. Remibrutinib for Chronic Spontaneous Urticaria: Clinical Impact and Future Directions. Published 2025. Accessed October 1, 2025. https://www.tandfonline.com/doi/abs/10.1080/1750743X.2025.2510892