MHRA (UK) approves cream for the treatment of adult patients with moderate to severe chronic hand eczema – Leo Pharma

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for LEO Pharma’s 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 across the hands and wrists. Its pathophysiology is characterised by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. Hand Eczema is categorised as CHE when it lasts for more than three months, or relapses twice or more often per year. The condition can have a high psychological, social, and occupational burden.

The MHRA decision was based on results from the delgocitinib cream phase III program, which included the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to the cream vehicle. Both trials met their primary and all secondary endpoints. Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial.

Prof. Richard Warren, Consultant Dermatologist at Northern Care Alliance NHS Foundation Trust and The University of Manchester said: “The physical symptoms of Chronic Hand Eczema can be debilitating, substantially disrupting patients’ lives. Additionally, patients report that the disease can profoundly affect their mental well-being, relationships, and daily activities. Today’s approval of a first, topical JAK inhibitor treatment option for moderate to severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.”