Cosmo Receives Negative CHMP Opinion on Winlevi(R) (clascoterone Cream 1%) in Europe and Will Appeal the Decision
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.
Cosmo Pharmaceuticals subisce una battuta d'arresto poiché il CHMP dell'Agenzia Europea per i Medicinali ha espresso un parere negativo su Winlevi (crema al clascoterone 1%) per il trattamento dell'acne. La decisione deriva principalmente da preoccupazioni riguardo la valutazione rischio-beneficio negli adolescenti di età compresa tra 12 e 17 anni, nonostante i risultati positivi negli adulti sopra i 18 anni.
L'azienda intende richiedere una riesamina, citando:
- Solide evidenze provenienti da due studi clinici multicentrici, randomizzati e in doppio cieco
- Un utilizzo efficace nella pratica reale, in particolare negli Stati Uniti
- Assenza di problemi di sicurezza emergenti in centinaia di migliaia di pazienti adolescenti
Il Prof. Andrea Lania dell'Università Humanitas ha espresso difficoltà a comprendere il parere negativo, dati i robusti dati clinici. L'amministratore delegato Giovanni Di Napoli ha manifestato delusione ma resta fiducioso nella validità scientifica di Winlevi, sottolineando che la decisione di includere gli adolescenti si basa sui dati e non su strategie. L'azienda continuerà il dialogo con l'EMA durante il processo di riesame.
Cosmo Pharmaceuticals enfrenta un revés tras la adopción de una opinión negativa por parte del CHMP de la Agencia Europea de Medicamentos sobre Winlevi (crema de clascoterona al 1%) para el tratamiento del acné. La decisión se basa principalmente en preocupaciones sobre la evaluación beneficio-riesgo en adolescentes de 12 a 17 años, a pesar de los resultados positivos en adultos mayores de 18 años.
La compañía planea solicitar una reexaminación, argumentando:
- Fuertes evidencias de dos ensayos clínicos multicéntricos, aleatorizados y doble ciego
- Uso exitoso en la práctica real, especialmente en Estados Unidos
- Ausencia de preocupaciones de seguridad emergentes en cientos de miles de pacientes adolescentes
El Prof. Andrea Lania de la Universidad Humanitas manifestó dificultad para entender la opinión negativa dada la solidez de los datos clínicos. El CEO Giovanni Di Napoli expresó decepción pero mantiene la confianza en la ciencia detrás de Winlevi, enfatizando que la decisión de incluir a los adolescentes se basó en datos y no en tácticas. La empresa continuará su diálogo con la EMA durante el proceso de reexaminación.
코스모 파마슈티컬스는 유럽 의약품청(EMA) CHMP가 여드름 치료제 윈레비(클라스코테론 크림 1%)에 대해 부정적인 의견을 채택하면서 어려움을 겪고 있습니다. 이 결정은 12-17세 청소년의 이익-위험 평가에 대한 우려에서 주로 비롯되었으며, 18세 이상 성인에서는 긍정적인 결과가 나타났음에도 불구하고 내려졌습니다.
회사는 다음을 근거로 재심사를 요청할 계획입니다:
- 두 건의 다기관, 무작위배정, 이중맹검 임상시험에서 나온 강력한 증거
- 특히 미국에서의 실제 사용 성공 사례
- 수십만 명의 청소년 환자에서 안전성 문제 발생 없음
휴머니타스 대학교의 안드레아 라니아 교수는 견고한 임상 데이터에도 불구하고 부정적 의견을 이해하기 어렵다고 밝혔습니다. CEO 조반니 디 나폴리는 실망감을 표명했으나 윈레비의 과학적 근거에 대한 신뢰를 유지하며, 청소년 포함 결정이 전략이 아닌 데이터에 기반했다고 강조했습니다. 회사는 재심사 과정에서 EMA와 지속적으로 협력할 예정입니다.
Cosmo Pharmaceuticals rencontre un revers suite à l'avis négatif du CHMP de l'Agence européenne des médicaments concernant Winlevi (crème de clascotérone à 1 %) pour le traitement de l'acné. Cette décision découle principalement de préoccupations liées à l'évaluation bénéfice-risque chez les adolescents de 12 à 17 ans, malgré des résultats positifs chez les adultes de plus de 18 ans.
L'entreprise prévoit de demander une réexamination, en s'appuyant sur :
- Des preuves solides issues de deux essais cliniques multicentriques, randomisés et en double aveugle
- Une utilisation réussie en conditions réelles, notamment aux États-Unis
- Aucune préoccupation de sécurité émergente chez des centaines de milliers d'adolescents
Le Professeur Andrea Lania de l'Université Humanitas a exprimé sa difficulté à comprendre cet avis négatif au vu des données cliniques solides. Le PDG Giovanni Di Napoli a exprimé sa déception mais reste confiant dans la science de Winlevi, soulignant que leur décision d'inclure les adolescents reposait sur des données et non sur des tactiques. L'entreprise poursuivra ses échanges avec l'EMA durant le processus de réexamen.
Cosmo Pharmaceuticals erleidet einen Rückschlag, da der CHMP der Europäischen Arzneimittel-Agentur eine negative Stellungnahme zu Winlevi (Clascoteron-Creme 1%) zur Aknebehandlung abgegeben hat. Die Entscheidung beruht hauptsächlich auf Bedenken hinsichtlich der Nutzen-Risiko-Bewertung bei Jugendlichen im Alter von 12 bis 17 Jahren, trotz positiver Ergebnisse bei Erwachsenen über 18 Jahren.
Das Unternehmen plant, eine erneute Prüfung zu beantragen und verweist auf:
- Starke Evidenz aus zwei multizentrischen, randomisierten, doppelblinden klinischen Studien
- Erfolgreiche Anwendung in der Praxis, insbesondere in den USA
- Keine neuen Sicherheitsbedenken bei Hunderttausenden von jugendlichen Patienten
Prof. Andrea Lania von der Humanitas Universität äußerte Verständnisprobleme angesichts der robusten klinischen Daten. Geschäftsführer Giovanni Di Napoli zeigte sich enttäuscht, bleibt jedoch von der Wissenschaft hinter Winlevi überzeugt und betonte, dass die Entscheidung, Jugendliche einzubeziehen, datenbasiert und nicht taktisch getroffen wurde. Das Unternehmen wird den Dialog mit der EMA während des erneuten Prüfungsverfahrens fortsetzen.
- 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
- 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.
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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.
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FAQ
Why did EMA reject Winlevi acne cream in Europe in April 2025?
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How successful is Winlevi in the US market where it's already approved?
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