Cosmo Receives Positive CHMP Opinion for Winlevi(R) for Treatment of Acne in Adults and Adolescents, Following Successful Re-Examination
Cosmo Pharmaceuticals (CMOPF) has received a positive CHMP opinion recommending European approval for Winlevi® (clascoterone 1% cream) for treating facial acne vulgaris in both adults and adolescents aged 12 to <18 years. This follows a successful re-examination of an initial negative opinion from April.
The approval marks a significant milestone as Winlevi® becomes the first-in-class topical anti-androgen therapy for Europe's largest acne treatment segment. The drug works by inhibiting androgen receptors in the skin, reducing sebum production and inflammation. The treatment is already approved in several markets including the United States, Canada, and the UK.
Cosmo is preparing to launch Winlevi® across 20 European markets, targeting a significant expansion of its addressable market, particularly in the adolescent population.
Cosmo Pharmaceuticals (CMOPF) ha ottenuto un parere positivo dal CHMP che raccomanda l'approvazione in Europa di Winlevi® (clascoterone 1% crema) per il trattamento dell'acne volgare del volto in adulti e adolescenti dai 12 ai <18 anni, a seguito della revisione positiva di un parere negativo emesso ad aprile.
Questo via libera rappresenta un traguardo importante: Winlevi® è il primo trattamento topico anti-androgeno della sua classe nel più grande segmento di mercato europeo per l'acne. Il farmaco agisce bloccando i recettori degli androgeni nella pelle, riducendo produzione di sebo e infiammazione. Il trattamento è già approvato in diversi paesi, tra cui Stati Uniti, Canada e Regno Unito.
Cosmo si sta preparando a lanciare Winlevi® in 20 mercati europei, puntando a espandere significativamente il mercato indirizzabile, in particolare nella popolazione adolescente.
Cosmo Pharmaceuticals (CMOPF) ha recibido una opinión positiva del CHMP que recomienda la aprobación en Europa de Winlevi® (clascoterona 1% crema) para el tratamiento del acné vulgar facial en adultos y adolescentes de 12 a <18 años, tras una reevaluación favorable de una opinión negativa inicial de abril.
La aprobación supone un hito relevante, ya que Winlevi® se convierte en la primera terapia tópica antiandrogénica de su clase en el mayor segmento de tratamiento del acné en Europa. El fármaco actúa inhibiendo los receptores de andrógenos en la piel, disminuyendo la producción de sebo y la inflamación. El tratamiento ya cuenta con aprobación en varios mercados, incluidos Estados Unidos, Canadá y Reino Unido.
Cosmo se prepara para lanzar Winlevi® en 20 mercados europeos, con el objetivo de ampliar significativamente su mercado direccionable, especialmente en la población adolescente.
Cosmo Pharmaceuticals (CMOPF)가 Winlevi®(클라스코테론 1% 크림)을 성인 및 12세에서 <18세까지의 청소년의 얼굴 여드름 치료용으로 유럽 승인을 권고하는 CHMP의 긍정적 의견을 받았습니다. 이는 4월의 초기 부정적 의견에 대한 재심사 결과입니다.
이번 승인은 중요한 이정표로, Winlevi®는 유럽에서 처음으로 도입되는 국소 항안드로겐 계열 치료제가 됩니다. 이 약물은 피부의 안드로겐 수용체를 억제해 피지 생성과 염증을 감소시킵니다. 해당 치료제는 이미 미국, 캐나다, 영국 등 여러 시장에서 승인받았습니다.
Cosmo는 유럽 20개 시장에서 Winlevi® 출시를 준비 중이며, 특히 청소년 인구에서 주소 지정 가능한 시장을 크게 확대하는 것을 목표로 하고 있습니다.
Cosmo Pharmaceuticals (CMOPF) a reçu un avis favorable du CHMP recommandant l'approbation européenne de Winlevi® (clascotérone crème 1%) pour le traitement de l'acné vulgaire du visage chez les adultes et les adolescents de 12 à <18 ans, à la suite d'une réexamination réussie d'un avis initial négatif en avril.
Cette approbation constitue une étape importante: Winlevi® devient le premier traitement topique anti-androgène de sa classe dans le plus grand segment de traitement de l'acné en Europe. Le médicament agit en inhibant les récepteurs androgéniques cutanés, réduisant la production de sébum et l'inflammation. Le traitement est déjà approuvé sur plusieurs marchés, notamment aux États-Unis, au Canada et au Royaume-Uni.
Cosmo se prépare à lancer Winlevi® dans 20 marchés européens, visant une expansion significative de son marché adressable, en particulier chez les adolescents.
Cosmo Pharmaceuticals (CMOPF) hat eine positive CHMP-Empfehlung erhalten, die die europäische Zulassung von Winlevi® (Clascoteron 1% Creme) zur Behandlung von Gesichtsakne vulgaris bei Erwachsenen und Jugendlichen im Alter von 12 bis <18 Jahren empfiehlt. Dies folgt auf eine erfolgreiche Neubenennung nach einer anfänglich negativen Stellungnahme im April.
Die Zulassung ist ein wichtiger Meilenstein: Winlevi® ist die erste ihrer Art als topisches Antiandrogen im größten Akne-Behandlungssegment Europas. Das Präparat wirkt, indem es Androgenrezeptoren in der Haut hemmt und dadurch die Talgproduktion und Entzündung reduziert. Die Behandlung ist bereits in mehreren Märkten zugelassen, darunter den USA, Kanada und dem Vereinigten Königreich.
Cosmo bereitet die Markteinführung von Winlevi® in 20 europäischen Märkten vor und strebt damit eine deutliche Ausweitung des adressierbaren Marktes an, insbesondere bei Jugendlichen.
- First-in-class topical anti-androgen therapy approved for both adults and adolescents in Europe
- Expansion into 20 European markets, significantly increasing addressable market
- Already approved in multiple major markets including US, Canada, and UK
- Minimal systemic absorption with proven safety profile
- Strong competitive advantage as the only topical anti-androgen solution for adolescents in Europe
- Previous negative CHMP opinion required re-examination process
- Usage in adolescents limited to facial application only
Dublin, Ireland--(Newsfile Corp. - August 27, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending European approval of Winlevi® (clascoterone
This recommendation for approval marks a significant expansion of Winlevi®’s European indication and positions Cosmo to deliver a first-in-class topical anti-androgen therapy to the largest acne treatment segment in the region. Winlevi® is already approved in the United States, Canada, the United Kingdom, Australia, Malaysia, Singapore and Jordan markets.
“The recommendation for approval by CHMP is a major strategic milestone for Cosmo,” said Giovanni Di Napoli, CEO of Cosmo. “It reflects the strength of our science, the quality of our engagement with regulators, and our deep commitment to advancing care in dermatology. Most importantly, it brings a breakthrough therapy to millions of adolescents and adults suffering from acne. This outcome is fully aligned with our Vision 2030 and unlocks a significant growth opportunity across Europe.”
In its previous review, the CHMP concluded that the benefit–risk balance of Winlevi® was negative for therapeutic use in adolescents (12 to <18 years of age), while considering the product approvable in adults; it recommended refusing marketing authorization for the indication Cosmo had applied for, namely the treatment of acne vulgaris in patients 12 years of age and older.
Following the initial CHMP refusal, Cosmo initiated a formal re-examination procedure and provided a deeper clinical assessment supported by leading dermatology experts and an expert Professor of endocrinology. The procedure also included the consultation of an Ad-Hoc Expert Group comprising dermatologists and endocrinologists. The CHMP has now concluded that the benefit-risk profile of Winlevi® is favourable for both adults and adolescents, recommending for the approval in both age groups, with usage in adolescents limited to facial application.
“This is a real breakthrough,” said Prof. Brigitte Dréno, founder member of the European Association of Dermato-Oncology, past president of the French Society of Dermatology, and member of the American Academy of Dermatology. “We’ve been waiting for an innovation like this – a topical anti-androgen that is well-tolerated, effective, and safe for adolescents. It will be a valuable addition to our treatment options.”
Winlevi® acts by inhibiting androgen receptors in the skin, reducing sebum production and inflammation – two key drivers of acne pathogenesis. Its novel mechanism of action, combined with minimal systemic absorption, makes it a compelling treatment option for both physicians and patients.
The adolescent population represents a large proportion of acne patients in Europe, and until now, had no access to a topical anti-androgen solution. The positive CHMP opinion significantly expands Winlevi®’s addressable market and is expected to materially contribute to Cosmo’s mid- and long-term growth trajectory.
Cosmo is already working at full speed with its commercial partners to prepare for launch across 20 European markets. “We are executing with urgency,” Cosmo-CEO Giovanni Di Napoli added. “This is Cosmo at its essence – focused, science-led, and relentlessly committed to delivering impact for patients and shareholders alike.”
A full summary of the product characteristics for Winlevi® are available from the EMA website at www.ema.europa.eu. Winlevi®, Cosmo and Cosmo logo are trademarks of Cosmo Pharmaceuticals N.V. or its related companies.
About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com.
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FAQ
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