By Siddhi Mahatole
(Reuters) -The U.S. Food and Drug Administration has approved Novartis’ oral treatment for patients with type of chronic inflammatory skin disease, the Swiss drugmaker said on Tuesday.
The twice-daily pill, Rhapsido, is approved for patients with symptoms of chronic spontaneous urticaria (CSU) despite standard therapies.
CSU is a long-term skin condition without a known cause, characterized by recurring hives – itchy, red welts – and sometimes swelling, lasting six weeks or more.
Rhapsido will cost $4,521 in the U.S. for 30 days and will be available to patients in the coming days, a company spokesperson told Reuters in an email.
The approval is based on results from two late-stage studies in which Rhapsido showed statistically significant improvements over placebo