Cosmo Pharmaceuticals Receives Regulatory Approval by the European Commission for Winlevi(R) in the EU, Following on the Positive CHMP Opinion

Rhea-AI Summary

Cosmo Pharmaceuticals (CMOPF) announced that the European Commission approved Winlevi (clascoterone 1% cream) for treatment of acne vulgaris in adults and adolescents aged 12 to <18 years (adolescent use limited to facial application) on 21 October 2025, following a positive CHMP opinion on 25 August 2025.

Cosmo said it is preparing commercial launches across 20 European markets with its partners. Winlevi is described as a first-in-class topical androgen-receptor inhibitor that acts locally in sebaceous glands and has prior approvals in the United States, United Kingdom, Canada, Australia and several other countries.

Positive

• EU approval for Winlevi on 21 Oct 2025
• Indicated for adults and adolescents 12 to <18 years
• Preparing launches across 20 European markets
• First-in-class topical androgen-receptor inhibitor
• Prior approvals in US, UK, Canada, Australia and others

Negative

• Adolescent use is limited to facial application

Dublin, Ireland--(Newsfile Corp. - October 21, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Commission has granted regulatory approval in the EU for Winlevi® (clascoterone 1% cream) for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. This formal approval came following on the positive recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 25^th of August 2025. Cosmo is already working at full speed with its commercial partners to prepare for launch across 20 European markets.

Acne vulgaris is among the most common skin conditions worldwide, affecting over 90 percent of people at some point in their lives and often leading to both physical and emotional consequences, including reduced self-esteem and quality of life. Conventional topical therapies can cause irritation or limited tolerability, and few options directly target the hormonal component of acne.

Winlevi® is the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen-receptor inhibitor acting locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects, supporting safe use in both males and females.

Giovanni Di Napoli, CEO of Cosmo, commented: “The regulatory approval of Winlevi® by the European Commission is another major corporate milestone for us in 2025. We expect it to contribute significantly to our Company's mid- and long-term growth. We are also delighted that we can now offer our compound to adolescents in Europe, who previously had no access to a topical anti-androgen solution for treating acne.”

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, said: “It’s exciting to see Winlevi® finally completed all regulatory milestones and is now ready for commercialisation. The dermatology community has been eager for a genuine breakthrough in acne therapy, a topical anti-androgen that’s both effective and well tolerated, including in adolescents. This is a meaningful advancement and a welcome new option for our patients.”

Winlevi® has already been approved in the United States, Canada, Australia, the United Kingdom, New Zealand, Jordan, Singapore, Malaysia, Mexico, South Korea, Kuwait and Egypt. Additional registrations are progressing as Cosmo and its partners continue to expand commercial access to this innovative acne therapy globally.

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

Jefferies Global Healthcare Conference, London, United Kingdom Berenberg European Conference, Windsor, United Kingdom ODDO BHF Forum, Lyon, France

November 17-20, 2025 December 1-4, 2025 January 8-9, 2026

For further information, please contact:

investor.relations@cosmohc.com

Attachments

PDF - English

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/271272

FAQ

What did Cosmo (CMOPF) announce on October 21, 2025 about Winlevi?

The company said the European Commission approved Winlevi for acne vulgaris in adults and adolescents 12 to <18 years on 21 Oct 2025.

Which patients are covered by the EU approval for Winlevi (CMOPF)?

Approval covers adults and adolescents aged 12 to <18 years, with adolescent use restricted to facial application.

When did the CHMP give a positive opinion for Winlevi (CMOPF)?

The CHMP issued a positive recommendation on 25 August 2025 prior to the EC approval.

How many European markets is Cosmo preparing to launch Winlevi (CMOPF) in?

Cosmo said it is preparing launches across 20 European markets with its commercial partners.

What is Winlevi's mechanism and why is it notable for investors in CMOPF?

Winlevi is described as the first-in-class topical androgen-receptor inhibitor that acts locally in sebaceous glands without systemic anti-androgen effects.

Has Winlevi been approved outside the EU before Cosmo's Oct 21, 2025 announcement?

Yes; Winlevi already had approvals in the United States, Canada, Australia, United Kingdom and several other countries.