FDA approves Winlevi to treat acne.- Cassiopea SpA.

Cassiopea SpA announced that the 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 annually, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago. Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation. Topical treatment options that target androgens, which largely drive sebum production and inflammation, presented a significant unmet need in the acne treatment market until now. Cassiopea’s first-in-class topical androgen receptor inhibitor, Winlevi, tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation. In pivotal clinical trials, Winlevi demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema. Winlevi is expected to be available in the United States in early 2021.