Novartis’ Rhapsido Wins FDA Approval As Oral BTKi For Chronic Spontaneous Urticaria; Offering First BTK Inhibitor Treatment

Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Rhapsido® (remibrutinib) as an oral therapy for adults with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite H1 antihistamine treatment. Taken as a pill twice daily, Rhapsido requires no injections or lab monitoring and is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. By blocking BTK activity, the therapy helps reduce the release of histamine and other proinflammatory mediators, offering a novel treatment pathway for CSU patients.

“CSU is a serious disease that can cause debilitating symptoms and unpredictable flares. It’s difficult to diagnose and manage,” said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and member of the steering committee for the remibrutinib REMIX Phase III clinical trial program. “Remibrutinib represents a new way of treating CSU. By blocking the activity of BTK, remibrutinib stops a key pathway of the immune response in CSU. This is an exciting new option that has the potential to help a broad range of patients get fast relief.”

CSU is a mast cell–driven disorder linked to immune dysregulation, where allergic (IgE) and autoimmune (IgG) pathways can activate mast cells and basophils through the BTK protein. Once triggered, BTK is believed to drive histamine and mediator release, leading to the hallmark hives, swelling, and itching. The disease is unpredictable and persistent, with symptoms lasting six weeks or longer without a clear cause. Diagnosing CSU can take up to two years, further complicating patient care.

“The approval of remibrutinib is an important development in CSU care. It quickly reduces symptoms, offering patients control of the hives and itching that they experience on a daily basis,” said Giselle Mosnaim, MD, MS, an Allergist and Immunologist from Endeavor Health, Clinical Associate Professor at the University of Chicago Pritzker School of Medicine and REMIX trial investigator. “This is significant because it expands beyond existing injectable treatments and gives patients an oral option that can easily be incorporated into their daily lives.”

CSU significantly impacts quality of life, with many patients reporting disruptions in sleep, work productivity, and mental health. Antihistamines are the standard first-line therapy, yet more than half of patients remain symptomatic despite higher doses. Injectable options exist but are underutilized, with fewer than 20% of eligible patients accessing them. With FDA approval, Rhapsido offers a much-needed oral alternative that expands treatment options for this underserved patient population.

“Many CSU patients feel misunderstood and settle for treatments that don’t fully meet their needs,” said Lynda Mitchell, CEO of Allergy & Asthma Network. “We support new treatment options that empower patients to choose what works best for them. This convenient new oral therapy offers a promising new way to manage CSU and potentially improve daily life for those living with this challenging condition.”