LEO Pharma has received Technology Appraisal Guidance (TAG) from the National Institute for Health and Care Excellence (NICE) for Anzupgo (delgocitinib) cream.
The decision means Anzupgo is now recommended for reimbursement in adult patients with moderate to severe chronic hand eczema (CHE) when topical corticosteroids have proven ineffective or are unsuitable.
CHE is a skin condition characterised by persistent itching, pain, redness and irritation on the hands and wrists. Symptoms may last for more than three months during a flare-up or recur several times a year. The condition can arise from a combination of factors, including a weakened skin barrier, chronic inflammation and changes in the skin microbiome.
It affects around one in ten adults, with severe cases often impairing patients’ ability to perform daily activities and maintain employment, significantly reducing quality of life.
Anzupgo cream is a topical pan-Janus kinase (JAK) inhibitor targeting the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE.
The NICE recommendation was supported by data from the DELTA 1, DELTA 2 and DELTA 3 phase 3 trials, which evaluated the safety and efficacy of Anzupgo cream compared to placebo, and the DELTA FORCE phase 3 trial, which assessed the treatment in combination with alitretinoin capsules.
Across the studies, Anzupgo achieved statistically significant and clinically meaningful improvements in Investigator’s Global Assessment for Chronic Hand Eczema Treatment Success (IGA-CHE TS) and Hand Eczema Severity Index (HECSI) scores.
“This approval is a huge moment for the many people living with CHE and for us at LEO Pharma,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland. “Delgocitinib is now the first NICE-approved topical treatment of its kind. NICE has recognised the need for equitable care, including how this condition shows up differently across skin tones. It’s a real step forward.”