EMA accepts marketing authorization for delgocitinib for chronic hand eczema

Key takeaways:

• If approved, delgocitinib will be the first topical treatment for chronic hand eczema.
• The application is supported by the DELTA phase 3 program.

The European Medicines Agency has validated the marketing authorization application for delgocitinib cream for moderate to severe chronic hand eczema treatment, LEO Pharma announced in a press release.

The acceptance of this marketing authorization for delgocitinib, an investigational product and topical pan-Janus kinase inhibitor for chronic hand eczema treatment in adults, marks the start of the formal review process.

“We are delighted that delgocitinib cream has entered this first stage of the European regulatory process,” Kreesten Meldgaard Madsen, MD, PhD, chief development officer of LEO Pharma, said in the release. “If approved, it will be the first topical treatment specifically indicated and developed for moderate to severe [chronic hand eczema].”

The validation is based on results from the phase 3 program which includes DELTA 1 and DELTA 2 — two phase 3 trials that evaluated the safety and efficacy of delgocitinib cream vs. vehicle. Both trials met all primary and secondary endpoints, which has led to the start of a DELTA 3, an open-label, multi-site extension trial that is still ongoing. Interim data from DELTA 3 was also used to support this acceptance.