LEO Pharma announces NICE recommendation of reimbursement in England and Wales

BALLERUP, Denmark, November 5, 2025 – LEO Pharma, a global leader in medical dermatology, today announced that the National Institute for Health and Care Excellence (NICE) has issued Technology Appraisal Guidance (TAG) recommending the reimbursement of Anzupgo® ▼(delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.¹ Anzupgo® ▼ is now the first approved topical pan-Janus kinase (JAK) inhibitor treatment for this indication in England and Wales.¹

CHE is a fluctuating inflammatory skin disease, characterised by persistent itch, pain, redness and irritation on the hands and wrists.⁶ The disease is diagnosed when these symptoms last more than three months, or when they return two or more times within a year.^7,8 People can develop CHE due to a combination of factors, including a weakened skin barrier, ongoing inflammation, and changes in the skin’s microbiome.⁹

“The NICE recommendation marks a pivotal moment in the treatment of moderate to severe chronic hand eczema in the United Kingdom,” said Prof. Richard Warren, The University of Manchester and Northern Care Alliance NHS Foundation Trust. “There have been limited treatment options for these patients. This recommendation provides a new, evidence-based option - an important step for patients living with what can be a debilitating disease.”

The NICE committee concluded that delgocitinib cream is an effective treatment for improving symptoms of CHE, based on robust clinical evidence from the DELTA 1, 2, 3 and DELTA FORCE trials.¹ It advised that delgocitinib should be started and monitored by a healthcare professional with experience in diagnosing and treating CHE in secondary care.¹ Clinicians should also consider how skin colour may influence the assessment of disease severity and make any adjustments needed.¹

“This approval is a huge moment for the many people living with chronic hand eczema 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, and I am proud to be able to bring this innovation to patients. What’s especially encouraging is how NICE has recognised the need for equitable care, including how this condition shows up differently across skin tones. It’s a real step forward. At LEO Pharma, we’re committed to making a meaningful difference by listening, learning and continuing to deliver treatments that help improve lives.”

The recommendation from NICE follows regulatory approvals of delgocitinib cream, among others including by the European Medicines Agency (EMA) in September 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in November 2024, and the U.S. Food and Drug Administration (FDA) in July 2025 for the treatment of moderate to severe Chronic Hand Eczema in adults.

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Notes to editors

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year.^7,8 CHE is one of the most common skin diseases of the hands¹⁰ with a global prevalence rate of approximately 4.7%.² In a substantial number of patients, HE can develop into a chronic disease.¹⁰ CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.⁶

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹¹ with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.⁴ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹²

About Anzupgo^® (delgocitinib) cream

Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹³ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁹

Delgocitinib cream is currently approved in the European Union, Switzerland, Canada, Australia, South Korea, the United Arab Emirates, the UK and the U.S. for the treatment of moderate-to-severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialise delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

According to the final Technology Appraisal Guidance (TAG) issued by NICE, delgocitinib can be used in England and Wales, within its marketing authorisation, as an option to treat moderate to severe CHE in adults when topical corticosteroids have not worked or are not suitable.¹ Delgocitinib should be started and monitored by a healthcare professional with experience in diagnosing and treating CHE in secondary care and healthcare professionals should consider how skin colour could affect the assessment of severity and make any adjustments needed.¹

About the DELTA 1, 2 and 3 Trials

The primary objective for the randomised, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of Anzupgo^® (delgocitinib) cream 20 mg/g (2%) compared with cream vehicle in the treatment of adults with moderate to severe CHE.¹⁴

The primary endpoint of the trials was the Investigator’s Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores are 2 (mild), 3 (moderate), and 4 (severe).¹⁴

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI). The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.¹⁴

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 open-label, multi-site extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.¹⁵

About the DELTA FORCE Trial

DELTA FORCE was a 24-week, randomised, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of Anzupgo^® (delgocitinib) cream twice-daily with oral alitretinoin capsules once-daily in adult participants with severe CHE.¹⁶

The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.¹⁶