MHRA Grants Marketing Authorisation for LEO Pharma’s Anzupgo® ▼(delgocitinib) cream in Great Britain

• The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation in Great Britain for Anzupgo^® (delgocitinib) 20mg/g cream for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.¹
• Delgocitinib cream is now the first approved topical pan-Janus kinase (JAK) inhibitor treatment specifically for adults with moderate to severe CHE.¹
• The authorisation introduces a new treatment option for adult patients in Great Britain living with moderate to severe CHE.

MAIDENHEAD, England--(BUSINESS WIRE)--LEO Pharma, a global leader in medical dermatology, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for 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

CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain across the hands and wrists.^2,3 Its pathophysiology is characterised by skin barrier dysfunction, skin inflammation, and skin microbiome alterations.² Hand Eczema is categorised as CHE when it lasts for more than three months, or relapses twice or more often per year.^3,4 The condition can have a high psychological, social, and occupational burden.^5,6

“The physical symptoms of Chronic Hand Eczema can be debilitating, substantially disrupting patients' lives. Additionally, patients report that the disease can profoundly affect their mental well-being, relationships, and daily activities,” shared Prof. Richard Warren, Consultant Dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester. “Today’s approval of a first, topical JAK inhibitor treatment option for moderate to severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.”

“Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe Chronic Hand Eczema,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland. “This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.”

The MHRA decision was based on results from the delgocitinib cream phase 3 program, which included the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to the cream vehicle.^7-9 Both trials met their primary and all secondary endpoints.^9-11 Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial.¹²

“CHE is a truly debilitating condition as patients may live with itchy, sore, scaly, weepy, fissured hands. This can really affect patients' ability to work but also to interact with family and loved ones,” noted Prof. Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust. “CHE is so much more than a difficult skin disease, as research has shown that living with CHE can have an impact on patients' psychological well-being, and can lead to anxiety, depression, or both. The development of a new topical treatment for adult patients with moderate to severe CHE is very welcome.”

LEO Pharma UK and Ireland is collaborating closely with NICE to make delgocitinib cream available on the NHS.

*Ends*

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.^3,4 CHE is one of the most common skin disorders of the hands¹³ with a prevalence rate of approximately 4.7%.¹⁴ In a substantial number of patients, HE can develop into a chronic condition.¹³ CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.⁵

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,⁶ 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.¹⁵ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁶

About 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 signalling, which plays a key role in the pathogenesis of CHE.¹⁷ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.²

Delgocitinib cream is currently approved in the European Union and Switzerland 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 commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. Anzupgo^® (delgocitinib) cream SmPC. LEO Pharma; December 2024.
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3. Lynde C, et al. J Cutan Med Surg. 2010;14:267–284. Erratum in: J Cutan Med Surg. 2011;15:360.
4. Diepgen TL, et al. J Dtsch Dermatol Ges. 2015;13(1):e1–22.
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6. Grant L, et al. Adv Ther. 2020;37(2):692-706.
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8. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04872101.
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10. Schliemann S, et al. European Academy of Dermatology and Venereology (EADV) Congress. 2023.
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12. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04949841.
13. Bissonnette R, et al. JEADV. 2010;24;1–20
14. Apfelbacher C, et al. European Society of Contact Dermatitis (ESCD) congress. 2024.
15. Cortesi PA, et al. Contact Dermatitis. 2014;70(3):158-168.
16. Voorberg AN, et al. Acta Derm Venereol. 2022;102:adv00626.
17. Dubin C, et al. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021:17:233.

MAT-78329 December 2024