LEO Pharma A S, a global leader in medical dermatology, has submitted an application to the European Medicines Agency requesting an expansion of the approved label for Anzupgo delgocitinib cream. The submission seeks approval for use in adolescents aged 12 to 17 years who are living with moderate to severe chronic hand eczema and for whom topical corticosteroids are not suitable or do not provide adequate relief. The EMA has confirmed that the application has been accepted for review.

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Sophie Lamle, Executive Vice President of Development at LEO Pharma, said the submission reflects the company’s continued focus on improving outcomes for people with serious skin conditions. She explained that adolescents in the European Union with moderate to severe chronic hand eczema currently have no treatment specifically approved for their condition. Lamle noted that advancing this application is an important step toward closing that gap and offering a therapy that could meaningfully improve daily life for young patients affected by this disease.

Studies involving adolescents with chronic hand eczema show that the condition affects more than the skin alone. The disease can significantly disrupt quality of life, with impacts on emotional well being, school performance, and participation in social and recreational activities. These broader effects highlight the need for effective and age appropriate treatment options.

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The application is supported by data from the DELTA TEEN study, a phase three clinical trial evaluating Anzupgo delgocitinib 20 mg per gram cream in adolescents aged 12 to 17 years with moderate to severe chronic hand eczema. The trial compared twice daily application of Anzupgo with a cream vehicle in patients who did not respond adequately to topical corticosteroids or could not use them. Detailed results from the study were presented as a late breaking presentation at the 2025 European Academy of Dermatology and Venereology congress in Paris.

Anzupgo is already approved in the European Union for adults with moderate to severe chronic hand eczema when topical corticosteroids are not appropriate or effective. The treatment is also approved in several other markets, including the United States, Switzerland, and the United Kingdom.

Chronic hand eczema is defined as eczema of the hands that persists for more than three months or recurs at least twice within a year. It is one of the most common conditions affecting the hands worldwide and can progress to a long term disease in many patients. Symptoms often include itching, pain, redness, scaling, thickened skin, swelling, blisters, and painful cracks, all of which can interfere with daily activities.

Research has shown that chronic hand eczema places a substantial psychological and functional burden on patients. Many individuals with severe disease report difficulty performing routine tasks and experience disruptions to work, education, and social life. Long term career prospects and earning potential may also be affected due to the ongoing nature of the condition.

Anzupgo delgocitinib cream is a topical pan Janus kinase inhibitor developed to treat moderate to severe chronic hand eczema. It works by blocking JAK STAT signaling pathways that are known to play a key role in the development and persistence of the disease. The cream is approved for adult use in multiple regions globally and continues to be evaluated in additional markets.

The DELTA TEEN trial was a sixteen week randomized double blind study conducted across multiple sites. Its primary goal was to assess treatment success at week sixteen, defined as clear or almost clear skin with a meaningful improvement from baseline. The results support the potential role of Anzupgo as a new treatment option for adolescents living with this challenging condition.

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