Cosmo Receives Negative CHMP Opinion on Winlevi(R) (clascoterone Cream 1%) in Europe and Will Appeal the Decision
Rhea-AI Summary
Cosmo Pharmaceuticals faces a setback as the European Medicines Agency's CHMP adopts a negative opinion on Winlevi (clascoterone cream 1%) for acne treatment. The decision primarily stems from concerns about the benefit-risk assessment in adolescents aged 12-17, despite positive results in adults over 18.
The company plans to request a re-examination, citing:
- Strong evidence from two multi-center, randomized, double-blind clinical trials
- Successful real-world usage, particularly in the United States
- No emerging safety concerns in hundreds of thousands of adolescent patients
Prof. Andrea Lania of Humanitas University expressed difficulty understanding the negative opinion given robust clinical data. CEO Giovanni Di Napoli voiced disappointment but remains confident in Winlevi's science, emphasizing their decision to maintain adolescent inclusion was based on data, not tactics. The company will continue engaging with EMA during the re-examination process.
Positive
- Strong real-world evidence of Winlevi's safety and efficacy in the US market with hundreds of thousands of patients treated
- Potential for market expansion in Europe pending successful re-examination
- Established positive benefit-risk profile for adult patients (18+ years) acknowledged by CHMP
Negative
- CHMP issued negative opinion for Winlevi's marketing authorization in Europe
- Failed to secure approval for adolescent population (12-17 years), a key target demographic
- Regulatory setback likely to delay European market entry and impact revenue potential
- Additional costs and time required for re-examination process
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® (clascoterone cream
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.
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.
Prof. Andrea Lania, Professor of Endocrinology, Humanitas University, commented: “As a clinician and researcher, I find the negative opinion difficult to understand given the robust clinical data supporting clascoterone. This is a therapy that has transformed acne management globally, with hundreds of thousands of patients treated. I support Cosmo’s intention to appeal and hope the EMA will reconsider this decision in light of the full evidence.”
Giovanni Di Napoli, CEO of Cosmo, added: “We are surprised and disappointed by the CHMP’s opinion, particularly given the well-established safety and efficacy profile of clascoterone in both clinical trials and extensive real-world use in adolescents and adults. While we acknowledge the Committee’s recognition of clinical value in adults, we made a deliberate and data-driven decision not to amend the proposed indication to exclude adolescents. This was not a tactical omission, but a principled stance based on robust global experience. In the United States alone, hundreds of thousands of adolescents have safely used Winlevi since approval, without any emerging safety concerns.”
Cosmo believes the CHMP’s current position does not reflect the totality of evidence supporting clascoterone across age groups and the urgent need for innovation in acne treatment, particularly for adolescents - the population most impacted by the condition.
“We remain fully confident in the science behind Winlevi,” continued Di Napoli, “and we look forward to engaging constructively through the re-examination process to ensure that patients across Europe — regardless of age — can access this important therapeutic option.”
Cosmo will continue to engage with the EMA throughout the re-examination process and will provide further updates in due course.
About Winlevi® (clascoterone cream
Winlevi is the first and only topical androgen receptor inhibitor for acne with a novel mechanism of action in almost 40 years. Winlevi has already been approved for use in both adults and adolescents in the United States, where it received FDA approval in 2020, and was subsequently approved by several other major regulatory agencies, including Health Canada, TGA (Australia) and was recently approved in the United Kingdom. To date, it has been prescribed to hundreds of thousands of patients globally and is widely regarded as a generally well tolerated and effective treatment option7, 8, 9, 10, 11, 12.
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
Financial calendar
| Ordinary Annual General Meeting of Shareholders | May 30, 2025 |
| Jefferies Healthcare Conference, New York | June 3-5, 2025 |
| Investor Day, Zurich | July 1, 2025 |
| 2025 Half-Year Results and Report | July 23, 2025 |
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Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
1 Bhatia et al. J. Drugs Dermatol. 2024 . 23(6) : 433-437
2 Herbert et al. JAMA Dermatology. 2020. 156(6) : 621-630
3 Eichenfield et al. J. Am. Acad. Dermatol. 2020. 83: 477-485
4 Herbert et al. J. Drugs Dermatol. 2023 . 22(2) : 174-181
5 Eichenfield et al. J. Drugs Dermatol. 2023. 22(8): 810-816
6 Eichenfield et al. J. Drugs Dermatol. 2024. 23(1): 1278-1283
7 Del Rosso et al. The Journal of Dermatological Treatment. 2024. 35(1), 2298878.
8 Manjaly et al. Drugs of Today. 2023. 59(2): 71–81.
9 Peterson et al. Journal of Drugs in Dermatology. 2023. 22(6 - Supplement 1): s7-s14.
10 Burma et al. Skin Therapy Letter 2022. “Topical Clascoterone for Acne Vulgaris”.
11 Lynde et al. J. Drugs Dermatol. 2025. 24(1 - Supplement 2): s3-s14.
12 Tay & Loo. Clinical, Cosmetic and Investigational Dermatology. 2025. 18: 161–167.
Attachments
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FAQ
Why did EMA reject Winlevi acne cream in Europe in April 2025?
What are the next steps for Cosmo Pharma after Winlevi's EMA rejection?
How successful is Winlevi in the US market where it's already approved?
What clinical evidence supports Winlevi's safety and efficacy?
How does the EMA rejection affect Cosmo Pharma's European market plans?
