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Novartis' Rhapsido tackles 2 most common forms of chronic hives with swift FDA expansion

Published

7 October 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at fiercepharma.com →

◆ Verified

Fusion42 · 11 October 2026 · Fusion42 review

Novartis' oral BTK inhibitor Rhapsido (remibrutinib) received FDA approval as the first treatment for symptomatic dermographism (SD) uncontrolled by H1 antihistamines, expanding its earlier chronic spontaneous urticaria (CSU) indication. This makes Rhapsido the only chronic hives drug approved for both SD and CSU, supported by late-stage trial data showing superior symptom control compared to placebo.

This Wire brief sits within Fusion42's coverage of Biotech, and 7 sources have reported it between 7 Oct 2026 and 10 Oct 2026.

◆ ◆ The Wire takeaway

You have new FDA-approved marketing opportunities with Rhapsido covering the two most common chronic hives types where antihistamines fail. Product teams can now differentiate by addressing symptomatic dermographism alongside spontaneous urticaria in the US market.

◆ Coverage

7 sources · first reported 7 Oct 2026 · latest 10 Oct 2026

◆ Related on Wire

◆ Topics

Biotechnovartisfda-approvalchronic-urticariaimmunologybtk-inhibitor