Glenmark Pharmaceuticals Secures European Approval for Winlevi® Acne Treatment
Glenmark Pharmaceuticals has received Marketing Authorization from the European Commission for Winlevi® (clascoterone 10 mg/g cream), a novel acne treatment, across 15 European countries. The approval covers the treatment of acne vulgaris in adults and adolescents aged 12 to 18 years. This marks Glenmark's first New Chemical Entity launch in Europe, strengthening its dermatology portfolio in the region. The authorization allows commercialization in various European markets, including countries in Northern, Western, Eastern, and Southern Europe. The approval resulted from a collaboration between Glenmark and Cosmo Pharmaceuticals N.V.

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Glenmark Pharmaceuticals , a global pharmaceutical company, has achieved a significant milestone in its European expansion strategy. The company has received Marketing Authorization (MA) from the European Commission (EC) for Winlevi® (clascoterone 10 mg/g cream), a novel acne treatment, across 15 European countries.
Key Highlights
- Product: Winlevi® (clascoterone 10 mg/g cream)
- Approval: Granted by the European Commission
- Indication: Treatment of acne vulgaris in adults and adolescents aged 12 to 18 years
- Market Reach: 15 European countries
Approval Details
The European Commission's decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This approval marks a significant expansion of Glenmark's dermatology portfolio in the European market.
Market Potential
With this authorization, Glenmark is set to commercialize Winlevi® across a diverse range of European markets, including:
| Region | Countries |
|---|---|
| Northern Europe | Denmark, Finland, Iceland, Norway, Sweden |
| Western Europe | France, The Netherlands |
| Eastern Europe | Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia |
| Southern Europe | Portugal, Spain |
Strategic Importance
Christoph Stoller, President & Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals, emphasized the strategic importance of this approval, stating, "Winlevi is the first NCE launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region."
Collaborative Effort
The approval is a result of a collaboration between Glenmark and Cosmo Pharmaceuticals N.V. Giovanni Di Napoli, Chief Executive Officer of Cosmo, highlighted that Winlevi represents a "first-in-class topical innovation that redefines how acne is treated."
Looking Ahead
This European approval for Winlevi® not only expands Glenmark's product portfolio but also potentially opens up new revenue streams in the competitive acne treatment market. The company's focus on timely market access and alignment with regulatory frameworks suggests a strategic approach to capitalizing on this opportunity.
As Glenmark Pharmaceuticals moves forward with the commercialization of Winlevi® in these European markets, investors and industry observers will be keen to see how this development impacts the company's market position and financial performance in the coming quarters.
Historical Stock Returns for Glenmark Pharmaceuticals
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -1.40% | +1.40% | -0.54% | +28.11% | +24.03% | +281.69% |
















































