26 December 2022 | News
Winlevi is a first-in-class topical drug for the treatment of acne approved by US FDA
Hyphens Pharma International, Singapore's specialty pharmaceutical and consumer healthcare group, has announced that its subsidiary, Hyphens Pharma Pte. Ltd., has entered into exclusive license and supply agreements with Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals N.V. (headquartered in Ireland) for the exclusive rights to develop and commercialise Winlevi® (clascoterone) cream 1% and all future product extension and/or improvement in the treatment of acne in 10 countries across Southeast Asia.
Winlevi is a US Food & Drug Administration (FDA) approved novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older. It is the first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new type of acne medication approved by the FDA since 1982.
As the only topical cream to treat hormonal acne directly in the skin, it offers a non-antibiotic approach for acne-sufferers everywhere. Winlevi inhibits sebum production and inflammation by targeting the androgen receptors in the sebaceous gland cells. Oral treatments are typically prescribed to address hormonal acne, but usually only prescribed to females. With Winlevi, males suffering from acne, as well as females who don't want to take oral medications, can now benefit from this first-in-class treatment, making Winlevi a game-changer in the fight against acne.
Launched in the US in November 2021, Winlevi is already the most prescribed branded topical acne drug in the US based on IQVIA data.
In a study involving 3,888 Singapore Chinese subjects, the estimated prevalence of acne vulgaris is 53.8%. Winlevi will be Hyphens Pharma's first innovative therapeutics, deepening its dermatology pipeline.