European Commission Approves LEO Pharma’s Anzupgo? (delgocitinib) Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE)

發(fā)布時(shí)間： 2024-09-27 閱讀：135次

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September 24, 2024 – LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Commission (EC) has granted marketing authorization for Anzupgo? (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.

CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain. Its pathophysiology is characterized by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. The condition can have a high psychological, social, and occupational burden.

Anzupgo? is the first topical treatment to be specifically indicated for adult patients living with moderate to severe CHE across the European Union (EU) for whom topical corticosteroids are inadequate or inappropriate. LEO Pharma also announced that the FDA has accepted for filing LEO Pharma’s New Drug Application (NDA) for delgocitinib cream in the United States.

The approval for Anzupgo is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of Anzupgo compared to cream vehicle.2-4 Both trials met their primary and all secondary endpoints