#Ireland #Dublin #Glenmark Pharmaceuticals #Winlevi #Cosmo Pharmaceuticals

Winlevi® Receives European Market Authorization

Cosmo Pharmaceuticals N.V. (SIX: COPN) and Glenmark Pharmaceuticals Limited have exciting news for acne treatment. On December 2, 2025, they announced that the European Commission granted marketing authorization for Winlevi® (clascotérone 10 mg/g cream) after a favorable recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency. This approval not only represents a significant milestone in dermatological care but also highlights the innovative approach both companies are dedicated to fostering.

Expanded Access for Teenagers and Adults

Winlevi® is primarily indicated for the treatment of adolescent acne in individuals aged between 12 to 18 years, although patients are limited to facial application. This targeted treatment approach is especially beneficial for teenagers, who often experience acne-related complications during a critical development phase. By addressing common concerns related to acne, Winlevi® promises to enhance self-esteem and the overall quality of life for adolescents navigating this common dermatological issue.

Market Launch in 17 European Countries

With this market authorization, Glenmark is set to propel Winlevi® into 17 European nations, including Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden. The anticipated roll-out of Winlevi® aims to make effective acne treatment widely accessible across various healthcare systems, indicating a significant step towards improving dermatological care standards in Europe.

Statements from Company Leaders

Giovanni Di Napoli, CEO of Cosmo, expressed enthusiasm about this approval, noting, "This is a reflection of our strong partnership with Glenmark and our joint commitment to advancing dermatological care. Winlevi represents a first-class topical innovation that redefines acne treatment, and we are thrilled to see it become available to patients across Europe."

Meanwhile, Christoph Stoller, President and CEO for Europe and Emerging Markets at Glenmark Pharmaceuticals, stated, "This approval marks a key step in realizing our mission to become a global research-driven pharmaceutical company. Winlevi is the first new chemical entity launched by Glenmark in Europe and is essential for strengthening our presence in dermatology in the region. We are committed to expediting accurate launches while ensuring swift patient access in compliance with regulatory frameworks."

About Winlevi® and Its Mechanism

Winlevi® utilizes clascotérone, a novel androgen receptor inhibitor, which effectively targets the underlying causes of acne. By modulating the action of androgens, Winlevi® reduces sebum production and inflammation, tackling two critical components of acne development. This innovative approach offers a new pathway for patients seeking alternative treatments that align with their healthcare needs and lifestyle.

Commitment to Healthcare and Innovation

Both Cosmo and Glenmark are at the forefront of developing pharmaceutical solutions that adhere to high standards of efficacy and safety. Their collaborative efforts emphasize the importance of continuous innovation within the healthcare sector.

Glenmark Pharmaceuticals is ranked among the top pharmaceutical companies globally, focusing on prescription drugs, generics, and over-the-counter medications across various therapeutic areas, including respiratory and dermatology applications.

Cosmo is recognized for its advancements in MedTech, dermatology, and gastroenterology, focusing on delivering high-quality medicines and cutting-edge technologies.

Together, Glenmark and Cosmo are empowered to leverage diverse competencies and drive meaningful advancements in the field of dermatology, aiming to improve health outcomes for individuals suffering from acne and related conditions.

Conclusion

The approval of Winlevi® signifies a new era in acne treatment, fostering hope for millions who struggle with this common condition. As it becomes available across Europe, patients can look forward to receiving effective, innovative treatments that contribute to better skin health and confidence. This partnership paves the way for further research and development in the field, addressing unmet needs in dermatological care worldwide.