Novartis (NVS) said late Tuesday the US Food and Drug Administration has approved Rhapsido for adult patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Chronic spontaneous urticaria is a skin condition characterized by the appearance of itchy hives and swelling.

The company said the approval was based on the results of two phase 3 trials, where Rhapsido demonstrated "superiority" in change from baseline, compared with placebo, in itch, hives, and weekly urticaria activity at week 12.