The FDA has expanded the indication of remibrutinib (Rhapsido), a Bruton's tyrosine kinase inhibitor, to include symptomatic dermographism, the most common form of chronic inducible urticaria. The oral agent is now approved as initial treatment for adults whose condition is inadequately controlled by H1 antihistamines. According to Novartis, remibrutinib is the first prescription drug approved for both chronic spontaneous urticaria and symptomatic dermographism, conditions that together occur in more than 90% of patients with chronic hives.
The approval is supported by the symptomatic dermographism cohort of the phase III RemIND trial, which enrolled patients who remained symptomatic despite second-generation H1 antihistamine treatment. At 12 weeks, the complete response rate was 29.3% in the remibrutinib group versus 14.0% in the placebo group (P=0.0229), meaning more than twice as many patients achieved a complete response. Some responses were observed as early as two weeks after starting treatment.
Safety data were consistent with earlier trials, with follow-up extending to 24 weeks. The most common adverse events, occurring in at least 3% of patients, included nasal congestion, sore throat, nasopharyngitis, bleeding, headache, nausea, and abdominal pain. In a company press release, Giselle Mosnaim, MD, of Endeavor Health and the University of Chicago Pritzker School of Medicine, described the approval as a meaningful step forward for patients with a chronic condition that has historically had limited treatment options.