Cosmo Pharmaceuticals announced its intention to appeal the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) decision, which denied marketing authorization for Winlevi® (clascoterone cream 1%) for treating acne vulgaris in adolescents. The company contends that the CHMP’s negative assessment overlooks substantial clinical and real-world evidence supporting the cream’s safety and efficacy in both adolescents and adults.
CHMP’s Stand on Winlevi for Adolescents
The CHMP’s unfavorable opinion primarily stems from concerns about the benefit-risk profile of Winlevi in patients aged 12 to 17, despite positive evaluations in those 18 and older. Cosmo argues that the committee failed to differentiate between these age groups, as the initial marketing application included adolescents. The company plans to present additional data from multiple clinical trials and extensive safety records to demonstrate Winlevi’s positive impact on acne management across all targeted age brackets.
Cosmo’s Strategic Response and Confidence
Giovanni Di Napoli, CEO of Cosmo, expressed disappointment with the CHMP’s decision, highlighting the product’s robust safety and efficacy proven in both clinical settings and extensive real-world use, particularly in the United States. He emphasized Cosmo’s principled stance in not limiting the product’s indication to exclude adolescents, reflecting global usage data where Winlevi has been safely administered to hundreds of thousands of young patients without emerging safety issues.
– CHMP’s opinion does not account for differentiated efficacy in adolescents versus adults.
– Real-world usage data strongly supports Winlevi’s safety profile in younger populations.
– Cosmo’s appeal aims to highlight comprehensive evidence across all age groups.
The ongoing dialogue between Cosmo and the EMA underscores the critical need for innovative acne treatments, especially for adolescents who are significantly affected by the condition. Winlevi, being the first topical androgen receptor inhibitor for nearly four decades, represents a novel therapeutic option that addresses unmet medical needs in dermatology.
With hundreds of thousands of patients benefiting from Winlevi globally, Cosmo remains steadfast in its commitment to providing effective acne treatments. The company anticipates that a successful appeal will facilitate broader access to Winlevi in Europe, thereby improving the quality of life for countless individuals struggling with acne vulgaris.
Moving forward, stakeholders and patients alike will be keenly observing the re-examination process. Cosmo’s proactive approach and confidence in its product’s merits position it strongly to advocate for the approval of Winlevi, ensuring that effective treatment options remain available to those in need.
Cosmo Pharmaceuticals continues to lead in dermatological innovation, leveraging extensive clinical research and real-world evidence to support its therapeutic offerings. The outcome of this appeal could set a precedent for future pharmaceutical evaluations and approvals within the European market.
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