(Reuters) -The U.S. Food and Drug Administration (FDA) on Friday approved Arcutis Biotherapeutics’ drug for treating a skin condition called seborrheic dermatitis in individuals nine years of age and older.
The health regulator’s nod makes roflumilast foam the first topical drug for treating moderate to severe seborrheic dermatitis with a new mechanism of action in over two decades, according to the company.
Seborrheic dermatitis, a common, chronic and recurrent inflammatory skin disease, affects more than 10 million people in the U.S., Arcutis said.
The drug is a foam-based formulation of the company’s roflumilast cream 0.3%, sold as Zoryve, which is approved in the U.S. as a topical treatment of plaque psoriasis in patients 6 years of age and older.
(Reporting by Pratik Jain in Bengaluru; Editing by Shailesh Kuber and Krishna Chandra Eluri)
