The expansion is targeted at individuals for whom topical corticosteroids are not sufficient or appropriate. The European regulator has accepted the application for review.
The submission is based on outcomes from the Phase III trial, DELTA Teen, which evaluated the safety and efficacy of Anzupgo 20mg/g cream applied twice daily against a cream vehicle in this patient group.
Detailed findings from the trial were shared as a late-breaking presentation at the European Academy of Dermatology and Venereology 2025, held in Paris, France.
Research indicates that CHE in adolescents can affect more than just the skin, with significant impacts on quality of life, psychosocial health and academic performance.
The therapy is approved for use in adults with moderate to severe CHE for whom topical corticosteroids are not appropriate or sufficient in the EU, Switzerland, the US, and the UK.
LEO Pharma obtained exclusive development and commercialisation rights in 2014 for the topical use of delgocitinib in dermatological indications globally, except in Japan where Shionogi holds the rights.
LEO Pharma Development executive vice-president Sophie Lamle stated: “With the submission of our label expansion application for Anzupgo, LEO Pharma is reinforcing our commitment aiming at improving the lives of patients with skin diseases.
“Adolescents living with this debilitating disease in the EU currently have no treatment options specifically approved for moderate to severe CHE, and we are proud to take this important step toward addressing that unmet need.
“Backed by our global expertise and dedication to innovation, we are excited about the potential to bring a treatment that can help make a meaningful difference in the everyday lives of adolescent patients.”