Novartis has officially received European Commission (EC) approval for Rhapsido® (remibrutinib), marking a historic shift in the management of chronic spontaneous urticaria (CSU). Rhapsido is now the first oral targeted therapy authorized in Europe for adults who remain symptomatic despite standard antihistamine use.
For the nearly 4 million people in Europe suffering from CSU, the disease is defined by more than just itchy hives; it is a source of chronic sleep deprivation, anxiety, and diminished quality of life. Globally, it affects approximately 40 million people, striking women nearly twice as often as men. Because the disease typically peaks between the ages of 20 and 40, it disrupts patients during their most vital years of career and family building. While injectable biologics have long been the only advanced option, Rhapsido introduces a highly selective Bruton’s tyrosine kinase (BTK) inhibitor in a convenient, twice-daily pill.
The approval is anchored by the pivotal Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) studies, which involved over 900 patients. The trials demonstrated that Rhapsido provides , near-immediate impact providing patients significant symptom improvement as early as Week 1. Superior reduction in itch and wheals compared to placebo through the 12-week primary endpoint. The drug was well-tolerated with no liver safety signals, uniquely requiring no routine laboratory monitoring a major advantage for patient lifestyle and clinical efficiency.
The 2026 International Urticaria Guidelines have already integrated Rhapsido as a recommended treatment for patients failing first-line therapy. “This approval is a major step forward,” said Patrick Horber, M.D., President, International at Novartis. “It offers patients faster relief and a simpler way to manage their disease while reinforcing the potential of our BTK platform across other immune-mediated conditions.”With this milestone, Novartis continues to lead the way in dermatology, providing a powerful, needle-free alternative that allows CSU patients to reclaim control over their daily lives.
The 2026 International Urticaria Guidelines have already integrated Rhapsido as a recommended treatment for patients failing first-line therapy. “This approval is a major step forward,” said Patrick Horber, M.D., President, International at Novartis. “It offers patients faster relief and a simpler way to manage their disease while reinforcing the potential of our BTK platform across other immune-mediated conditions.”With this milestone, Novartis continues to lead the way in dermatology, providing a powerful, needle-free alternative that allows CSU patients to reclaim control over their daily lives.
