FDA Approves Remibrutinib for Adults With CSU

The US Food and Drug Administration (FDA) has approved remibrutinib (Rhapsido, Novartis) as the first oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of chronic spontaneous urticaria (CSU) in adults whose symptoms persist despite H1 antihistamine therapy, Novartis announced. Taken twice daily, remibrutinib offers a non-injectable, laboratory monitoring–free option for CSU management.

The approval is based on findings from the REMIX Phase III clinical trial program, which evaluated remibrutinib’s ability to reduce the activity of BTK—a key signaling molecule implicated in mast cell and basophil activation. By inhibiting BTK, the drug disrupts the release of histamine and other proinflammatory mediators associated with CSU flares.

“Remibrutinib represents a new way of treating CSU,” said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and a member of the REMIX steering committee. “This is an exciting new option that has the potential to help a broad range of patients get fast relief.”

CSU is thought to involve both IgE- and IgG-mediated immune activation pathways, leading to BTK activation.

“Remibrutinib expands beyond existing injectable treatments and gives patients an oral option that can easily be incorporated into their daily lives,” said Giselle Mosnaim, MD, MS, allergist and immunologist at Endeavor Health and REMIX investigator.

Patient advocates also welcomed the news.

“Many CSU patients feel misunderstood and settle for treatments that don’t fully meet their needs,” said Lynda Mitchell, CEO of the Allergy & Asthma Network. “This convenient new oral therapy offers a promising new way to manage CSU and potentially improve daily life.”