FDA approves Novartis’ Rhapsido for CSU

The US Food and Drug Administration (FDA) has approved Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

Rhapsido, developed by Swiss pharma giant Novartis (NOVN: VX), is a pill taken twice daily and does not require injections or lab monitoring.

“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 Dr Giselle Mosnaim, an allergist and immunologist from Endeavor Health, Clinical Associate Professor at the University of Chicago Pritzker School of Medicine and REMIX trial investigator, adding: “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.”