LEO Pharma has announced that its Anzupgo (delgocitinib) cream has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat chronic hand eczema (CHE).

The treatment has been authorised for use in adults with moderate-to-severe cases of the inflammatory skin disease for whom topical corticosteroids are inadequate or inappropriate.

CHE 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 itch and pain, the condition has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients with severe cases reporting problems performing everyday activities.

LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE, and is now the first topical pan-JAK inhibitor treatment approved by the MHRA specifically for adults with moderate-to-severe CHE.

The regulator’s decision, which comes less than three months after the European Commission approved Anzupgo for the same indication, was supported by esults from the phase 3 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 CHE 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.

Data from the 36-week DELTA 3 open-label extension trial also informed the approval.

Leanne Walsh, vice president and general manager, LEO Pharma UK and Ireland, said the approval “marks a significant milestone for adults in Great Britain living with moderate-to-severe CHE”.

LEO said it is now “collaborating closely” with the National Institute for Health and Care Excellence to make Anzupgo cream available on the NHS.