CHMP Recommends LEO Pharma's Anzupgo for Adolescents With Chronic Hand Eczema
核心洞察
The CHMP has recommended expanding Anzupgo (delgocitinib) cream to adolescents aged 12 to 17 with moderate to severe chronic hand eczema (搜索) in the EU.
If the European Commission approves, Anzupgo would be the first therapy in the EU specifically approved for this adolescent population.
The opinion is supported by the phase 3 DELTA TEEN trial, which met its primary endpoint of IGA-CHE treatment success at Week 16.
LEO Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a label expansion for Anzupgo (delgocitinib) cream to include adolescents aged 12 to 17 years with moderate to severe chronic hand eczema (搜索) for whom topical corticosteroids (搜索) are inadequate or inappropriate in the European Union.
If approved by the European Commission, Anzupgo would become the first therapy in the EU specifically approved for adolescents with moderate to severe chronic hand eczema (搜索). LEO Pharma noted that no treatment options are currently specifically approved for adolescent patients in the EU, and that topical corticosteroids (搜索) are not always adequate or appropriate. Adolescents with the condition may experience itch, pain, blistering and swelling, and the disease can affect daily activities, school, social confidence and caregiver well-being.
The opinion is supported by DELTA TEEN, a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel-group, multi-site trial of twice-daily Anzupgo versus cream vehicle in adolescents aged 12 to 17 years. The primary endpoint was Investigator's Global Assessment for chronic hand eczema (搜索) treatment success at Week 16, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. The trial met the primary endpoint and key secondary endpoints.