The FDA approved Rhapsido, a new oral drug, for adults with chronic hives unresponsive to antihistamines.

The FDA has approved remibrutinib, sold as Rhapsido by Novartis, as the first oral Bruton’s tyrosine kinase inhibitor for adults with chronic spontaneous urticaria who don’t respond to standard antihistamines. The twice-daily pill reduces hives, itching, and swelling by targeting mast cell activity, with significant symptom improvement seen in clinical trials within 12 weeks and lasting up to a year. Nearly half of patients achieved minimal or no symptoms, and the drug showed a favorable safety profile with mostly mild side effects.