European Commission Approves Anzupgo® Cream for Chronic Hand Eczema Treatment by LEO Pharma

LEO Pharma A/S, a global leader in dermatology, has announced that the European Commission (EC) has granted marketing authorization for Anzupgo® (delgocitinib) cream, designed for adults with moderate to severe chronic hand eczema (CHE) where topical corticosteroids are either ineffective or unsuitable. The approval extends across all EU member states, Iceland, Norway, and Liechtenstein.

This marks a major milestone for LEO Pharma, which also revealed that the U.S. FDA has accepted its New Drug Application (NDA) for delgocitinib cream. According to CEO Christophe Bourdon, the approval of Anzupgo underscores the company’s commitment to improving care for patients with skin conditions.

Anzupgo is the first topical pan-JAK inhibitor approved specifically for moderate to severe CHE, blocking JAK-STAT signaling, a key pathway involved in CHE pathogenesis. Currently, there are no other approved treatments for this condition targeting patients unresponsive to topical corticosteroids.

Kreesten Meldgaard Madsen, LEO Pharma's Chief Development Officer, emphasized the significant efforts behind this achievement, noting that Anzupgo offers a vital new option for managing CHE, which is characterized by inflammation, skin barrier dysfunction, and high psychological and occupational burdens.

The EC approval is based on data from the DELTA 1 and DELTA 2 clinical trials, which demonstrated the cream’s safety and effectiveness compared to a placebo cream. Both studies met their primary and secondary goals, showing significant improvements in symptoms such as itch and pain. An open-label extension trial, DELTA 3, is currently evaluating the long-term safety of Anzupgo.

Chronic hand eczema, affecting around 4.7% of the population, often becomes a persistent condition, causing pain, itching, and significant impact on daily life and work. The approval of Anzupgo is expected to bring much-needed relief to patients with limited treatment options.