The Food and Drug Administration (FDA) has granted Fast Track designation to delgocitinib cream (Leo Pharma) for the treatment of adults with moderate to severe chronic hand eczema.

Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that blocks the activation of the JAK-STAT pathway, which has been shown to play a key role in the pathophysiology of chronic inflammatory skin diseases.

The Company recently completed 2 multicenter, randomized phase 2b clinical trials (NCT03683719 and NCT03725722) investigating the efficacy and safety of twice-daily topical delgocitinib cream for the treatment of adults with mild to severe chronic hand eczema and mild to severe atopic dermatitis. Results from these studies will be submitted for publication later this year. Additionally, data from a vehicle-controlled, phase 2a study evaluating delgocitinib ointment in patients with chronic hand eczema showed that the topical treatment was efficacious based on improvement in the Physician’s Global Assessment of disease severity score at 8 weeks.

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“We are delighted that topical delgocitinib cream has been granted Fast Track designation and look forward to collaborating with the FDA during the development process as we aim to accelerate bringing this potential new treatment option to patients,” said Kim Kjøller, MD, Executive Vice President, Global Research and Development, LEO Pharma.

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1. LEO Pharma announces US Food and Drug Administration Fast Track designation for delgocitinib cream for the treatment of adults with moderate-to-severe chronic hand eczema. Accessed August 4, 2020.