Novartis receives FDA approval for Rhapsido to treat symptomatic dermographism
The U.S. Food and Drug Administration approved Novartis’ oral BTK inhibitor remibrutinib, marketed as Rhapsido, for adults whose symptomatic dermographism does not improve with H1‑antihistamine therapy. The decision follows the Phase III RemIND trial, which showed a higher proportion of patients achieving complete hive resolution compared with placebo. Novartis said the drug is now the sole U.S. prescription option covering both chronic spontaneous urticaria and symptomatic dermographism.
Why it matters
The approval expands Rhapsido’s market reach, giving Novartis an additional revenue source in the immunology segment, as noted by the company’s press release. Analysts at Zacks note that the label expansion could strengthen Novartis’ immunology portfolio amid generic pressure on other products.
Key facts
- 1The FDA approved Rhapsido (remibrutinib) for adults with symptomatic dermographism on October 7, 2026. tradingview.com
- 2In the RemIND Phase III trial, 29.3% of patients on Rhapsido achieved complete hive resolution at Week 12 versus 14.0% on placebo. finanznachrichten.de
- 3Responses were observed as early as Week 2. finanznachrichten.de
- 4The safety profile in symptomatic dermographism matched that seen in chronic spontaneous urticaria, with common adverse events including nasopharyngitis, bleeding, headache, nausea and abdominal pain. zacks.com
- 5Novartis plans to submit the full RemIND dataset to regulators worldwide and to explore additional indications such as cold urticaria, cholinergic urticaria, hidradenitis suppurativa, food allergy and multiple sclerosis. zacks.com
- 6Novartis shares rose about 2.4% in Zurich and were up roughly 10% year‑to‑date after the announcement. marketscreener.com
Summary written by AlphAI from 15 of 15 sources. Not investment advice. Figures are as stated by the linked sources.