Delgocitinib approved in Europe for the treatment of chronic hand eczema

The European Commission has approved delgocitinib, a topical pan-JAK inhibitor, 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 to a vehicle cream. According to a press release from LEO Pharma, which developed the drug, both trials met their primary and secondary endpoints, and participants were offered enrollment in the DELTA 3 open-label extension trial of 36 weeks.

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

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