On September 30, 2025, Novartis announced the FDA approval of Rhapsido® (remibrutinib), marking it as the first oral Bruton’s tyrosine kinase inhibitor (BTKi) approved for the treatment of chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine therapy. This breakthrough offers a new, targeted approach to managing CSU, a condition that affects approximately 1.7 million individuals in the United States.
Rhapsido works by targeting BTK, which plays a critical role in the immune response associated with CSU. By inhibiting BTK, Rhapsido can effectively prevent the release of histamine and other proinflammatory mediators, providing patients with symptom relief that can be observed in as little as two weeks after initiation of therapy.
“CSU is a serious disease that can lead to significant discomfort and disruption in daily life,” stated Dr. Mark Lebwohl, an expert in clinical therapeutics and an investigator in the REMIX clinical trial program. “The introduction of remibrutinib offers an innovative treatment option that has shown promise in delivering quicker relief from the debilitating symptoms associated with CSU.”
Clinical trials, including the Phase III REMIX-1 and REMIX-2 studies, demonstrated that patients taking Rhapsido experienced significant improvements in itch severity, hives, and overall urticaria activity compared to those receiving a placebo. By Week 12, a substantial proportion of Rhapsido-treated patients achieved well-controlled disease status, with about one-third experiencing a complete absence of itch and hives.
Given its oral administration and favorable safety profile—requiring no lab monitoring—Rhapsido presents a convenient alternative to existing injection-based treatments. This aligns well with the goals of improving patient adherence and quality of life.
As Dr. Giselle Mosnaim from Endeavor Health noted, “The approval of remibrutinib enhances the care available for CSU patients, providing a much-needed oral option that integrates easily into daily routines.” The advancement of Rhapsido serves as a vital step forward in the management of chronic spontaneous urticaria, potentially transforming the treatment landscape for many patients who struggle with this condition.
For the complete press release, please click HERE.
Elevate-Derm Alliance Editorial Committee