Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido (remibrutinib), an oral, highly selective Bruton's tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. (Novartis Press Release) - Oct 7, 2026 - "The FDA approval is based on data from the SD cohort of the Phase III RemIND clinical trial in patients who remained symptomatic on second-generation H1 antihistamines...The company plans to submit the full RemIND dataset to health authorities globally, where appropriate."
FDA approval • Immunology • Urticaria
|