The approval of WINLEVI brings the first truly new mechanism of action in acne treatment in nearly 40 years.
Lainate, Italy - Cassiopea SpA (SIX: SKIN), 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.
Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation2. 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.
“The approval of WINLEVI is an exciting breakthrough in acne treatment. This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy.” said Michael Gold, M.D., Investigator and Medical Director, Gold Skin Care Center and Tennessee Clinical Research Center. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”
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 inflammation3.
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 erythema4,5.
Diana Harbort, CEO of Cassiopea, said: “This milestone approval marks the introduction of a new class of topical medication in Dermatology. Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females. We are proud to bring this new innovation to acne patients. This approval rewards many years of hard work and positions Cassiopea as a leader in Dermatology. Now we look forward to expanding our franchise and advancing our next investigational drug candidate for androgenetic alopecia.”
WINLEVI is expected to be available in the United States in early 2021. Complete prescribing information is available on www.WINLEVI.com.
About Winlevi® (clascoterone cream 1%):
Winlevi® (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people aged 12 and older. Although WINLEVI’s exact mechanism of action is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles6.
Dr. Chris Tanner, CFO & Head of Investor Relations
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- The American Academy of Dermatology. Skin conditions by the numbers. American Academy of Dermatology. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed August 20, 2020.
- Lai J-J, Chang P, Lai K-P, et al. Arch Derm Res. 2012;304(7):499-510
- Elsaie ML. Clin Cosmet Investig Dermatol 2016;9:241–8.
- Hebert A, et al JAMA Dermatol. 2020;156(6):621-630
- Eichenfield, L., et al. JAAD Published:April 26, 2020.. https://www.jaad.org/article/S0190-9622(20)30703-9/fulltext
- Rosette C, et al. J Drugs Dermatol. 2019; 18(5):412-418. https://www.ncbi.nlm.nih.gov/pubmed/31141847