EMA accepts marketing authorization application for delgocitinib cream in chronic hand eczema

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).

The MAA for delgocitinib cream is based on results from the phase III program, which includes the DELTA 1 and DELTA 2 phase III clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle. Both trials met their primary and all secondary endpoints. 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. The efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority.

“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.