Glenmark inks pact to market Cosmo Pharma acne treatment Winlevi in Europe, South Africa

Professor Alison Layton (Associate Medical Director for Research, Harrogate and District NHS Foundation Trust) concludes: “The ability to reduce sebum in acne with a topical agent has up until now been a significant unmet need. Sebum is integral in the pathophysiology of all acne severities. Whereas there are effective systemic therapies including oral isotretinoin for severe acne and hormonal treatments for females, these are not advocated or tolerated by all people with acne. Clascoterone offers a novel topical approach for acne. In vitro testing suggests it is the first topical agent to reduce androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes. It could be prescribed as monotherapy or as part of an acne regime including fixed topical combinations and/or systemic antibiotics. All patient populations with acne could potentially receive and benefit from clascoterone.”

Winlevi has been approved by the United States Food & Drug Administration (U.S. FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older. Winlevi has become the most prescribed branded topical acne drug in the U.S.; with over 15,000 U.S. health care providers, representing 88% of total health care providers in dermatology, having prescribed Winlevi to date (per IQVIA MAT June 2023).

According to the prescriptions generated as measured by IQVIA data, Winlevi has been one of the most successful U.S. launches in the topical acne space in the last 15 years. The EU acne market is projected to grow from USD 928.7 million in 2021 to USD 1,297.0 million in 2028. Across Europe, over 90% of people aged 11 to 30 years are affected by acne; with a rising prevalence among teenagers, which is driving the market's growth. European guidelines discourage the use of topical antibiotics for comedonal acne due to the risk of antibiotic resistance, and despite the many treatments currently available there is still a clear unmet need.

"With its non-antibiotic approach and by targeting the androgen receptors directly in the skin, Winlevi addresses aspects of underlying acne causing disease pathways by decreasing sebum production and inflammation. It has the potential to be the first product with an innovative mechanism of action to be available to patients in Europe in over 40 years," the release stated.

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