EC Approves LEO Pharma’s Anzupgo Cream for Chronic Hand Eczema

LEO Pharma has received approval from the European Commission (EC) for Anzupgo (delgocitinib) cream to treat adults suffering from moderate-to-severe chronic hand eczema (CHE) who have not responded well or are unsuitable for topical corticosteroids. The cream is the first topical treatment specifically indicated for this patient group in the European Union.

Chronic hand eczema is an inflammatory skin condition characterized by hand eczema that persists for over three months or recurs at least twice within a year. The disease manifests through physical symptoms such as fluctuating itch and pain, and it imposes psychological and functional burdens that significantly impair the quality of life. Studies show that around 70% of patients with severe CHE face difficulties in performing everyday activities.

Anzupgo is designed to inhibit the JAK-STAT signalling pathway, essential in the development of CHE. The European Medicines Agency’s human medicines committee recently recommended the approval, which was bolstered by positive outcomes from the DELTA 1 and DELTA 2 late-stage clinical trials. These trials assessed the safety and effectiveness of the cream compared to a vehicle cream. Both studies met the primary endpoint, the Investigator’s Global Assessment for chronic hand eczema treatment success at week 16. Additionally, all secondary endpoints were achieved, such as a significant reduction in itch and pain scores by at least four points, measured by the Hand Eczema Symptom Diary from baseline to week 16.

Further supporting the approval was data from the 36-week DELTA 3 open-label extension trial, which showed a consistent safety profile and sustained treatment success. This comprehensive data package played a crucial role in the EC's decision to approve Anzupgo.

Christophe Bourdon, LEO Pharma’s chief executive officer, expressed optimism about the approval, stating, “This approval provides a new treatment option for patients, and we look forward to coordinating the next steps required to provide Anzupgo to those patients who need it.”

In addition to the European approval, LEO Pharma announced that their new drug application for delgocitinib cream to treat CHE has been accepted for filing by the US Food and Drug Administration (FDA). The regulatory review process in the United States is anticipated to conclude in the second half of 2025. Bourdon commented on their efforts in the US, saying, “Alongside our ongoing efforts in Europe, we will approach our work to provide delgocitinib cream in the US with the same determination and dedication.”

Overall, the approval of Anzupgo by the European Commission marks a significant advancement for patients suffering from chronic hand eczema, offering a new therapeutic option where previous treatments have been inadequate or unsuitable. The support from rigorous clinical trials demonstrates the potential of Anzupgo in managing this burdensome condition, paving the way for further regulatory approvals and expanding its availability to patients in need.