LEO Pharma announces that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“We are delighted that delgocitinib cream has entered this first stage of the European regulatory process. If approved, it will be the first topical treatment specifically indicated and developed for moderate to severe CHE,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma and points to the company’s dedication to advancing the standard of care for the benefit of people with skin conditions, their families, and society.

“Chronic hand eczema negatively impacts patients’ quality of life, psychological well-being, physical functioning, and ability to work. Despite a one-year prevalence of around 9%, there are currently no topical treatments specifically approved for the treatment of moderate to severe CHE. The strong clinical data enclosed in this submission brings hope to patients and reflects LEO Pharma’s continued commitment to addressing the critical unmet need in CHE,” says Dr Jacob Pontoppidan Thyssen, Executive Vice President and Chief Scientific Officer, LEO Pharma.

LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe CHE in adults. CHE is a heterogenous, fluctuating, inflammatory skin disease with key symptoms of itch and pain, with a high psychological, social, and occupational burden, that warrants specifically developed treatments.There are currently no treatments specifically approved for moderate to severe CHE that provide both short-term efficacy and long-term disease control.1 Delgocitinib cream is a first-in-class investigational topical pan-JAK inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.

The MAA for delgocitinib cream is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 phase 3 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle.6,7 Both trials met their primary and all secondary endpoints.8,9 The MAA is also based on interim data from the DELTA 3 open-label, multi-site extension trial, which is still in progress and is evaluating the long-term safety of delgocitinib cream.10 The efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority.