The treatment is indicated for adults with moderate-to-severe chronic hand eczema.
LEO Pharma has announced that the European Medicines Agency (EMA) has approved the marketing authorisation application (MAA) for delgocitinib cream.
Delgocitinib cream is an investigational therapy and topical pan-Janus kinase inhibitor for the treatment of adults with moderate-to-severe chronic hand eczema (CHE).
The provision of this MAA signals the commencement of a formal review procedure by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
CHE is a fluctuating, heterogenous and inflammatory skin condition with symptoms including itching and pain, along with a high psychological, social and occupational burden. It is also a disease that warrants specifically developed treatments.
The cream inhibits the activation of JAK-STAT signalling, which plays a significant role in the pathogenesis of CHE. The pathophysiology is defined by skin barrier dysfunction, inflammation of the skin and alterations of the skin microbiome.
At present, there are no treatments approved for moderate-to-severe CHE that provide both short-term efficacy and long-term disease control.
The MAA is based on results from phase 3 research, which includes the DELTA 1 and DELTA 2 phase 3 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to a cream vehicle. Each of the trials met its primary and secondary endpoints.
Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, explained: “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.”
Dr Jacob Pontoppidan Thyssen, executive vice president and chief scientific officer at LEO Pharma, concluded: “CHE 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.”