Cosmo Receives Positive CHMP Opinion for Winlevi(R) for Treatment of Acne in Adults and Adolescents, Following Successful Re-Examination

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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 1% cream) for the treatment of facial acne vulgaris in both adults and adolescents aged 12 to <18 years. The decision follows a successful re‑examination of the initial negative CHMP opinion issued in April.

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.

Financial calendar

H.C. Wainwright 27th Annual Global Investment Conference, New York City, USA Jefferies Global Healthcare Conference, London, United Kingdom ODDO BHF Forum, Lyon, France

September 8-10, 2025 November 17-20, 2025 January 8-9, 2026

For further information, please contact:
investor.relations@cosmohc.com

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264080

FAQ

What is the significance of CHMP's positive opinion for Winlevi (CMOPF) in Europe?

The positive opinion recommends European approval of Winlevi® for treating facial acne in both adults and adolescents (12-18 years), making it the first-in-class topical anti-androgen therapy in Europe's largest acne treatment segment.

How does Winlevi work in treating acne?

Winlevi® works by inhibiting androgen receptors in the skin, which reduces sebum production and inflammation - two key drivers of acne pathogenesis. It features minimal systemic absorption.

In which countries is Winlevi already approved?

Winlevi® is currently approved in the United States, Canada, United Kingdom, Australia, Malaysia, Singapore, and Jordan.

What are the age restrictions for Winlevi in Europe?

Winlevi® is approved for adults and adolescents aged 12 to under 18 years, with adolescent usage limited to facial application only.

What is Cosmo's commercialization plan for Winlevi in Europe?

Cosmo is preparing to launch Winlevi® across 20 European markets through its commercial partners, aiming to expand its addressable market significantly.