LEO Pharma’s Anzupgo (delgocitinib) cream has been approved by the US Food and Drug Administration (FDA) to treat adults with moderate-to-severe chronic hand eczema (CHE).

Patients eligible for the steroid-free pan-Janus kinase (JAK) inhibitor, which is now the first treatment approved by the regulator specifically for this population, will have had an inadequate response to, or not be advised, topical corticosteroids.

CHE is defined as hand eczema that lasts for more than three months or relapses at least twice within a year, and is characterised by fluctuating itch and pain.

Alongside physical symptoms, the inflammatory skin condition has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients who live with severe cases reporting problems performing everyday activities.

LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, suppressing the various inflammatory responses that play a key role in the onset and subsequent flares of CHE.

The therapy met the primary endpoint, Investigator’s Global Assessment for CHE treatment success at week 16, in the phase 3 DELTA 1 and DELTA 2 trials, as well as all secondary endpoints, 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.

It also demonstrated a consistent safety profile and sustained treatment success in the 36-week DELTA 3 open-label extension study.

Robert Spurr, executive vice president and president, North America, LEO Pharma, said: “CHE can be a very difficult disease for adults to manage, especially given the lack of treatment options in the US until now.

“As the first and only FDA-approved treatment specifically for CHE in the US, Anzupgo further establishes our company’s… commitment to bringing treatments to market that address unmet needs in medical dermatology.”