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, Berkshire, UK, Tuesday 3 December 2024 – 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.
