Novartis’ Rhapsido receives first FDA approval for symptomatic dermographism
Novartis announced that the FDA approved its BTK inhibitor Rhapsido (remibrutinib) for adults with symptomatic dermographism who do not respond to H1 antihistamines. The approval is based on the Phase 3 RemIND trial, which showed a complete response in 29.3% of patients after 12 weeks versus 14.0% on placebo. The drug is priced at $4,521 for a 30‑day supply and carries bleeding risks that require procedural pauses. The label expansion gives clinicians an on‑label oral option for a condition previously treated only off‑label.
Why it matters
The new indication provides the first prescription therapy specifically for symptomatic dermographism, potentially expanding market share for Novartis in chronic urticaria. However, the modest response rate and high price may limit uptake and affect reimbursement decisions.
Key facts
- 1The FDA approved Rhapsido for symptomatic dermographism on Oct. 7, 2026. medicaldaily.com
- 2In the Phase 3 RemIND trial, 29.3% of patients on Rhapsido achieved a complete response at week 12, compared with 14.0% on placebo. medicaldaily.com
- 3The trial enrolled 58 patients on Rhapsido and 57 on placebo, with 17 and 8 achieving complete response respectively. hcplive.com
- 4Novartis lists the price of Rhapsido at $4,521 for a 30‑day supply of 60 tablets as of Jan. 7, 2026. medicaldaily.com
- 5Common side effects include nasal congestion, sore throat, bleeding, headache, nausea and abdominal pain; 9% of patients in earlier hives studies experienced skin or mucous‑membrane bleeding. medicaldaily.com
- 6The label advises pausing treatment three to seven days before and after surgical procedures. medicaldaily.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.