Novartis' Rhapsido Gets US FDA Approval for Symptomatic Dermographism

MT Newswires · 2d ago
11:45 PM EDT, 10/07/2026 (MT Newswires) -- Novartis (NOVN.SW) received the US Food and Drug Administration's approval for Rhapsido as the first treatment for adults with symptomatic dermographism insufficiently controlled by H1 antihistamines. The authorization was supported by data from the symptomatic dermographism cohort of the late-stage RemIND clinical trial in patients who remained symptomatic on second-generation H1 antihistamines. In the study, patients treated with the oral drug exhibited higher rates of complete response from hives compared with placebo as measured by the Total Fric Score. Rhapsido's safety profile in symptomatic dermographism aligned with that of chronic spontaneous urticaria. Novartis said Rhapsido is now the only treatment approved for chronic spontaneous urticaria and symptomatic dermographism, the two most common types of chronic hives.