FDA Expands Indication for Urticaria Drug to Treat Symptomatic Dermographism

The FDA expanded the indication of the Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib (Rhapsido) to treat symptomatic dermographism, the most common form of chronic inducible urticaria, Novartis announced Thursday.

The approval allows use of the oral agent as initial treatment for adults with symptomatic dermographism inadequately controlled by H1 antihistamines. Remibrutinib becomes the first prescription drug approved for both chronic spontaneous urticaria and symptomatic dermographism, collectively occurring in more than 90% of patients with chronic hives.

“SD [symptomatic dermographism] is a chronic, debilitating condition with historically limited treatment options,” said Giselle Mosnaim, MD, of Endeavor Health and the University of Chicago Pritzker School of Medicine, in the company press release. “Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled by H1 antihistamines alone, representing a meaningful step forward for this population.”

Principal support for the approval came from the symptomatic dermographism cohort of the phase III RemIND trial of patients with chronic inducible urticaria that remained symptomatic despite treatment with second-generation H1 antihistamines. Participants who received the BTK inhibitor had higher rates of complete response compared with the placebo group as determined by the Total Fric Score. At 12 weeks, more than twice as many participants in the remibrutinib group met criteria for complete response (29.3% vs 14.0%, P=0.0229). Responses were observed as early as 2 weeks after starting remibrutinib.

Remibrutinib had a consistent safety profile in clinical trials with follow-up to 24 weeks. The most common adverse events (≥3% of patients) were nasal congestion, sore throat, nasopharyngitis, bleeding, headache, nausea, and abdominal pain.