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Cosmo Receives Negative CHMP Opinion on Winlevi(R) (clascoterone Cream 1%) in Europe and Will Appeal the Decision
Ad hoc announcement pursuant to Art. 53 LR Dublin, Ireland--(Newsfile Corp. - April 29, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the marketing authorization application (MAA) for Winlevi® ...
About this update from Cosmo Pharmaceuticals Nv
[{"type":"text","content":"Ad hoc announcement pursuant to Art. 53 LR","length":42,"tagName":"p"},{"type":"text","content":"Dublin, Ireland--(Newsfile Corp. - April 29, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the marketing authorization application (MAA) for Winlevi® (clascoterone cream 1%) for the treatment of acne vulgaris.","length":357,"tagName":"p"},{"type":"text","content":"The opinion is principally based on the CHMP’s negative benefit-risk assessment on the therapeutic use of Winlevi in adolescents (12 to 17 years of age), despite the fact that such an assessment is demonstrably positive in adults (18 years of age and older). It is plain that the CHMP opinion did not differentiate between these two demographic subsets of the population, probably in view of the fact that the initially submitted application for marketing authorization sought approval for treatment of acne vulgaris in patients from the age of 12 years.","length":560,"tagName":"p"},{"type":"text","content":"Cosmo will request a re-examination of the adopted opinion as it does not reflect the clinically meaningful and statistically significant beneficial effects of Winlevi in treating patients with acne vulgaris from 12 years and above based on the evidence derived from the two multi-centre, randomised, double-blind clinical trials, and the substantial safety characterization data to support a favorable benefit-risk assessment for the product to be used in adolescents and adults1, 2, 3, 4, 5, 6. The safe and effective conditions of Winlevi are further supported by real-world evidence. In countries where Winlevi is already approved especially the United States where the product has been used safely in adolescents since its approval, no emerging safety concerns have been identified. The growing body of evidence continues to support a favorable benefit-risk balance of the product in adolescents and adults. Cosmo remains confident that Winlevi will serve as a potential treatment option for acne vulgaris which is a common chronic disease that may be associated with impairment of quality of life.","length":1103,"tagName":"p"},{"type":"text","content":"Prof. Andrea Lania, Professor of Endocrinology, Humanitas University, commented: ...