Cassiopea Receives FDA Approval for Winlevi® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor
The approval of WINLEVI brings the first truly new mechanism of action in acne treatment in nearly 40 years
Cassiopea SpA, today announced that the United States Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the most prevalent skin condition in the U.S. affecting up to 50 million Americans annually1, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.