Anzupgo Receives Positive CHMP Opinion for Adolescent CHE

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication for 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, according to a press release.

If the European Commission approves the label expansion, Anzupgo would become the first therapy in the European Union (EU) specifically approved for adolescents with moderate to severe CHE, according to the announcement from LEO Pharma. Anzupgo is currently approved in the EU for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.

DELTA TEEN Supports Delgocitinib in Adolescent Chronic Hand Eczema

The positive CHMP opinion is supported by data from the DELTA TEEN trial, a phase 3, randomized, double-blind, vehicle-controlled, parallel-group, multisite trial evaluating twice-daily Anzupgo vs vehicle in adolescents aged 12 to 17 years with moderate to severe CHE. The primary endpoint was Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline. According to the data in the press release, the study met its primary endpoint and key secondary endpoints. The European Commission will make the final decision on the proposed label expansion.

“[The] positive CHMP opinion marks an important step toward making Anzupgo available to adolescent patients living with moderate to severe chronic hand eczema in the EU,” Sophie Lamle, executive vice president of development at LEO Pharma, said.

Source

LEO Pharma press release. September 18, 2026.