#None #Glenmark #Cosmo #Winlevi

Winlevi® Cream Approved in Europe

In a significant development for dermatology, Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have announced that the European Commission has granted marketing authorization for Winlevi® (clascoterone) 10 mg/g cream, targeting the treatment of acne vulgaris. This comes after a favorable review by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025.

Approval Details

Winlevi® is now authorized for use in 17 European countries, including Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden. The cream is approved for both adults and adolescents aged 12-<18, although its application in adolescents is limited to facial areas.

The significance of this approval cannot be overstated. Giovanni Di Napoli, CEO of Cosmo, expressed excitement stating, "This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care. Winlevi represents a first-in-class topical innovation that redefines how acne is treated, and we are excited to see it become accessible to patients throughout Europe."

Glenmark's Commitment

Christoph Stoller, President and Business Head for Europe at Glenmark, echoed similar sentiments, highlighting the approval as a key milestone in their mission to establish a robust footing in the dermatology sector. He indicated that the launch of Winlevi® is particularly important as it marks Glenmark's first new chemical entity (NCE) introduction in Europe.

"We are committed to executing successful launches with urgency and precision, ensuring timely access for patients while fully aligning with regulatory frameworks," Stoller emphasized, reinforcing the company's dedication to advancing healthcare in dermatology.

About Winlevi®

Winlevi® is dubbed a first-in-class treatment option. It works through a unique mechanism of action that is set to redefine acne management strategies for clinicians and patients alike. Unlike many traditional acne treatments, Winlevi® aims to mitigate the condition without the common side effects often associated with systemic therapies.

As the product becomes available in these European markets, dermatologists are eager for an option that prioritizes both efficacy and patient safety. The new-age formulation may become a cornerstone in the treatment of acne vulgaris, especially in teenagers, a demographic often plagued by the skin condition's psychosocial impacts.

About Cosmo and Glenmark

Glenmark Pharmaceuticals is recognized as a research-driven global pharmaceutical firm. The company maintains an extensive portfolio across branded, generic, and over-the-counter segments, with a concentrated focus on therapeutic areas, such as respiratory, dermatology, and oncology. Glenmark operates 11 manufacturing facilities across four continents and has a strategy to expand its dermatological footprint in Europe.

Cosmo Pharmaceuticals, headquartered in Dublin, Ireland, is noted for innovating within MedTech AI, dermatology, and gastrointestinal therapies. The company is dedicated to providing advanced solutions that elevate medical care standards globally, characterized by their commitment to meeting critical medical needs.

Conclusion

The recent approval of Winlevi® signifies a progressive move in acne treatment within Europe, illustrating the efficacy that collaboration between pharmaceutical firms can achieve. As Cosmo and Glenmark prepare for the roll-out of this groundbreaking cream, patients and healthcare providers alike remain hopeful for its positive impact on dermatological care across the continent.