MHRA Approves LEO Pharma's Anzupgo for Chronic Hand Eczema

LEO Pharma has recently announced that its Anzupgo (delgocitinib) cream has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of chronic hand eczema (CHE). This new treatment is specifically authorized for adult patients with moderate-to-severe instances of this inflammatory skin condition, particularly for those who find topical corticosteroids insufficient or unsuitable.

Chronic hand eczema is characterized by eczema affecting the hands that persists for over three months or recurs at least twice within a year. This condition is not only marked by physical symptoms such as itching and pain but also poses significant psychological and functional challenges, thereby affecting the quality of life. Studies indicate that around 70% of severe CHE patients encounter difficulties in performing daily tasks.

Anzupgo by LEO Pharma is formulated to inhibit the JAK-STAT signaling pathway, which is instrumental in the development of CHE. This makes Anzupgo the first topical pan-JAK inhibitor sanctioned by the MHRA for adult patients with moderate-to-severe chronic hand eczema.

The UK regulator's approval came swiftly, within three months of the European Commission's endorsement for the same use, supported largely by successful outcomes from the phase 3 DELTA 1 and DELTA 2 clinical trials. These trials assessed the safety and efficacy of Anzupgo cream compared to a vehicle cream. The primary goal was to achieve success in CHE treatment as evaluated by the Investigator’s Global Assessment at week 16, which was accomplished in both trials. Additionally, all secondary objectives were met, including a significant reduction in itch and pain scores by at least four points, as recorded in the Hand Eczema Symptom Diary from the start of the study to week 16.

Moreover, data from the 36-week DELTA 3 open-label extension trial also played a role in the approval process.

Leanne Walsh, vice president and general manager of LEO Pharma UK and Ireland, highlighted this approval as a major advancement for adults in Great Britain suffering from moderate-to-severe CHE. Richard Warren, a consultant dermatologist at Northern Care Alliance NHS Foundation Trust and The University of Manchester, also commented on the approval, noting the debilitating nature of CHE's physical symptoms and how this new topical JAK inhibitor treatment could enhance the range of options available to patients and healthcare providers.

LEO Pharma is currently working closely with the National Institute for Health and Care Excellence (NICE) to facilitate the availability of Anzupgo cream through the NHS.