Delgocitinib Approved in Europe for Chronic Hand Eczema

The European Commission has approved the topical pan-JAK inhibitor delgocitinib for adults with moderate to severe hand eczema, for whom topical corticosteroids are inadequate or inappropriate, the manufacturer announced on September 23.

The development is based on results from the phase 3 program of delgocitinib cream (Anzupgo), which includes the DELTA 1 and DELTA 2 trials that evaluated the safety and efficacy of delgocitinib cream compared with a vehicle cream. According to a press release from LEO Pharma, which has developed the drug, both trials met their primary and all secondary endpoints, and participants were offered to enroll in the 36-week DELTA 3 open-label extension trial.

The company release added that the approval of delgocitinib follows the recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from the DELTA phase 3 program.

In a separate press release issued on September 23, LEO Pharma announced that the US Food and Drug Administration has accepted the New Drug Application for delgocitinib cream for chronic hand eczema in the United States and that the review process is expected to conclude in the second half of 2025.