Novartis (NYSE: NVS) announced that the U.S. Food and Drug Administration has approved Rhapsido (remibrutinib) as a treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.

Rhapsido is an oral, selective Bruton's tyrosine kinase inhibitor. The approval makes it the only prescription treatment with approved indications for both chronic spontaneous urticaria (CSU) and SD when antihistamines alone do not control symptoms, according to the company.

The FDA decision is based on data from the Phase III RemIND clinical trial. At Week 12, 29.3% of patients treated with Rhapsido achieved a complete response from hives compared to 14.0% in the placebo group (p=0.0229), with responses observed as early as Week 2. The trial measured outcomes using the Total Fric Score.

In clinical trials up to Week 24, the most common adverse events, occurring in 3% or more of patients, included nasal congestion, sore throat, nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

Novartis stated it plans to submit the full RemIND dataset to health authorities globally. The RemIND study also evaluated remibrutinib in cold urticaria and cholinergic urticaria.

Rhapsido is already approved in the European Union, United Kingdom, and China for adults with CSU inadequately controlled by H1 antihistamines. Remibrutinib is also being studied in hidradenitis suppurativa, food allergy, and relapsing multiple sclerosis. Novartis recently reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis.