FDA expands remibrutinib approval to symptomatic dermographism

The FDA expanded approval of remibrutinib, sold as Rhapsido, to treat symptomatic dermographism in adults whose symptoms are inadequately controlled by H1 antihistamines, Novartis announced. MedPage Today reported that remibrutinib is now the first prescription drug approved for both symptomatic dermographism and chronic spontaneous urticaria, conditions that together occur in more than 90% of patients with chronic hives.

The approval was supported by the phase 3 RemIND trial. At 12 weeks, 29.3% of participants taking remibrutinib had a complete response, compared with 14.0% taking placebo (P=0.0229), MedPage Today reported. Responses were observed as early as 2 weeks. The report said clinical trials with follow-up to 24 weeks showed a consistent safety profile. Common adverse events included nasal congestion, sore throat, nasopharyngitis, bleeding, headache, nausea and abdominal pain.