BALLERUP, Denmark — September 18, 2026
LEO Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending expansion of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate. If the European Commission approves the recommendation, Anzupgo would become the first therapy specifically approved in the European Union for adolescents with moderate to severe CHE, addressing a population that currently has no specifically approved treatment option.
DELTA TEEN Phase 3 Trial Supports Label Expansion
The positive CHMP opinion is supported by results from the DELTA TEEN Phase 3 trial, a 16-week, randomized, double-blind, vehicle-controlled, multi-site study evaluating twice-daily Anzupgo in adolescents with moderate to severe CHE. The trial compared delgocitinib cream with a cream vehicle in patients aged 12 to 17 years for whom topical corticosteroids were inadequate or inappropriate. The primary endpoint was Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16, defined as an IGA-CHE score of 0, indicating clear skin, or 1, indicating almost clear skin, together with at least a two-step improvement from baseline. DELTA TEEN met its primary endpoint and key secondary endpoints, providing the clinical evidence supporting the proposed adolescent indication..
Anzupgo Targets Unmet Need in Adolescent Hand Eczema
Chronic hand eczema can create substantial functional and psychosocial burdens for adolescents, with symptoms including itch, pain, blistering and swelling potentially interfering with school, social activities and everyday tasks. CHE is defined as hand eczema lasting more than three months or recurring at least twice within a year and is characterized by fluctuating symptoms such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema and fissures. Anzupgo is a topical pan-Janus kinase (JAK) inhibitor that works by inhibiting JAK-STAT signaling, a pathway involved in the development of CHE. The potential adolescent indication would provide a non-steroidal topical treatment option for patients for whom topical corticosteroids are inadequate or inappropriate.
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LEO Pharma Expands Anzupgo International Dermatology Reach
Anzupgo is already approved in the EU for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, with approvals also in the United Kingdom, Switzerland, Canada, Australia, South Korea and the United Arab Emirates. In the United States, delgocitinib cream is FDA approved for moderate to severe CHE in adults with an inadequate response to topical corticosteroids or for whom corticosteroids are not advisable. The European adolescent expansion would further broaden the product’s potential patient population and strengthen LEO Pharma’s medical dermatology portfolio. With positive Phase 3 evidence from DELTA TEEN and a favorable CHMP opinion, LEO Pharma is advancing Anzupgo toward a potential European label expansion for adolescent patients with moderate to severe chronic hand eczema.
Source: LEO Pharma, press release
