LEO Pharma’s investigational Janus kinase (JAK) inhibitor cream Anzupgo (delgocitinib) has been recommended by the European Medicines human medicines committee to treat adults with moderate-to-severe chronic hand eczema (CHE).

CHE, an inflammatory skin disease, is defined as hand eczema that lasts for more than three months or relapses at least twice within a year.

Alongside physical symptoms such as fluctuating itch and pain, CHE has been shown to cause psychological and functional burdens that impact quality of life.

LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE, and has been specifically recommended for use in patients who have had an inadequate response to, or have not been advised, topical corticosteroids.

If approved, Anzupgo would be the first topical treatment specifically indicated for this patient population.

The Committee for Medicinal Products for Human Use’s (CHMP) recommendation was based on positive results from the late-stage DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream.

The primary endpoint, Investigator’s Global Assessment for chronic hand eczema treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16.

Also supporting the CHMP’s decision was data from the 36-week DELTA 3 open-label extension trial, which demonstrated a consistent safety profile and sustained treatment success.

Kreesten Meldgaard Madsen, chief development officer at LEO, said: “Our hands are integral to every aspect of our day-to-day lives, so avoiding physical triggers can be challenging for people living with CHE…  I am incredibly proud of this milestone and we will now continue our work to support those living with CHE.”