LEO Pharma’s Anzupgo (delgocitinib) cream has been approved by the European Commission (EC) to treat adults with moderate-to-severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.
The pan-Janus kinase (JAK) inhibitor is now the first topical treatment specifically indicated for this patient population in the EU.
CHE, an inflammatory skin disease, is defined as hand eczema that lasts for more than three months or relapses at least twice within a year.
In addition to physical symptoms such as fluctuating itch and pain, CHE has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients who live with severe cases of the condition reporting problems performing everyday activities.
LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE.
The approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream.
The primary endpoint, Investigator’s Global Assessment for chronic hand eczema treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16.
Data from the 36-week DELTA 3 open-label extension trial, which demonstrated a consistent safety profile and sustained treatment success, also informed the regulator’s decision.
LEO’s chief executive officer, Christophe Bourdon, said: “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.”
The company has also announced that its new drug application for delgocitinib cream in CHE has been accepted for filing by the US Food and Drug Administration, with the regulatory review process expected to conclude in the second half of 2025.
Bourdon said: “Alongside our ongoing efforts in Europe, we will approach our work to provide delgocitinib cream in the US with the same determination and dedication.”