Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Rhapsido (remibrutinib), an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy. Taken twice daily as a pill, Rhapsido is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU, offering a novel approach by targeting BTK to inhibit the release of histamine and other proinflammatory mediators.
Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, emphasized the challenges of diagnosing and managing CSU, which causes debilitating symptoms and unpredictable flares. He described remibrutinib as an exciting new treatment that blocks a key immune pathway, potentially providing fast relief for a broad range of patients.
CSU is a mast cell-driven disorder caused by immune dysregulation that activates BTK through allergic or autoimmune pathways, leading to the release of histamine responsible for red, swollen, and itchy hives. Symptoms persist for six weeks or longer, and diagnosis can take up to two years. Many patients suffer impacts on sleep, work, and mental health, and over half continue to experience symptoms despite antihistamines. Injectable treatments exist but are underutilized, with fewer than 20% of eligible patients receiving them.
Giselle Mosnaim, MD, an allergist and REMIX trial investigator, highlighted that remibrutinib offers a convenient oral option that can quickly reduce symptoms, expanding treatment beyond injectables. Lynda Mitchell, CEO of Allergy & Asthma Network, welcomed the approval as a promising new way to empower patients managing this challenging condition.