The U.S. Food and Drug Administration announced Wednesday that it has expanded the approved use of Novartis’ drug remibrutinib, sold under the brand name Rhapsido, to treat adults with symptomatic dermographism. This condition, a form of chronic hives, causes itchy welts to appear when the skin is scratched, rubbed, or otherwise irritated.
First FDA‑approved therapy for a specific chronic hives condition
Remibrutinib becomes the first FDA‑approved medication specifically indicated for adults whose symptoms of symptomatic dermographism are not adequately managed with standard antihistamines. The drug was already approved for chronic spontaneous urticaria, another common type of chronic hives, and this new indication broadens its reach to patients with the friction‑triggered form of the disease.
Clinical trial results support the decision
In a late‑stage study, 29.3% of patients receiving remibrutinib achieved complete resolution of hives after 12 weeks, compared with 14% of patients given a placebo. Participants began noticing improvements as early as two weeks after starting treatment. The safety profile was consistent with earlier studies, with the most common side effects reported as nasal congestion, sore throat, headache, nausea, and abdominal pain.
Implications for Novartis and the broader drug pipeline
The approval adds momentum to Novartis’ pipeline at a time when the company has faced setbacks with other late‑stage programs, including the cholesterol‑lowering agent pelacarsen and the muscle‑wasting therapy del‑desiran. Investors have been closely watching the progress of remibrutinib, especially after positive trial data in relapsing multiple sclerosis, a disease in which the immune system attacks the nervous system.
What patients and physicians can expect
Physicians now have a targeted option for patients whose chronic hives are triggered by skin friction and who have not found relief with antihistamines. The drug’s oral administration and relatively rapid onset of symptom relief may improve quality of life for many sufferers.
Regulatory background
The FDA’s decision follows a thorough review of the clinical data submitted by Novartis. The agency highlighted the unmet medical need for a therapy that addresses the specific mechanism of symptomatic dermographism, distinguishing it from broader hives treatments.
Novartis said it will work with healthcare providers to ensure the new indication is incorporated into treatment guidelines and that patients across the United States can access Rhapsido where appropriate.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
