Delgocitinib cream, marketed as Anzupgo, has received marketing authorization from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of moderate to severe chronic hand eczema (CHE) in adults. This approval offers a new treatment option for patients when topical corticosteroids are inadequate or unsuitable.
The MHRA decision follows positive results from the Phase III DELTA 1 and DELTA 2 clinical trials, which demonstrated the efficacy and safety of delgocitinib cream compared to a vehicle cream. These trials met both primary and secondary endpoints. Participants from DELTA 1 and DELTA 2 were also offered the opportunity to enroll in DELTA 3, a 36-week open-label extension study.
Leanne Walsh, Vice-President and General Manager of LEO Pharma UK and Ireland, emphasized the significance of this approval, stating that it represents a “significant milestone” for adults in Great Britain living with this challenging condition. This approval provides a new treatment paradigm and underscores LEO Pharma’s dedication to addressing unmet needs in dermatology.
Delgocitinib cream works by targeting the JAK-STAT signaling pathway, a key player in the pathogenesis of CHE. This condition is characterized by skin barrier dysfunction, inflammation, and alterations in the skin microbiome.
This latest MHRA approval builds upon existing authorizations for delgocitinib cream in the European Union and Switzerland for the same indication. LEO Pharma secured exclusive global development and commercialization rights for the cream in dermatological applications, excluding Japan, through a licensing agreement with Japan Tobacco (JT) in 2014. JT retains the rights in Japan. The European Commission (EC) also granted marketing authorization for delgocitinib cream for the treatment of moderate to severe CHE in September 2024.
LEO Pharma UK and Ireland is actively collaborating with the National Institute for Health and Care Excellence (NICE) to ensure access to delgocitinib cream through the National Health Service (NHS).
Chronic hand eczema is a complex and varied inflammatory skin condition primarily affecting the hands and wrists, causing debilitating symptoms such as itching and pain. This approval provides a new treatment avenue for individuals struggling with this condition. LEO Pharma’s commitment to addressing unmet needs in dermatology brings hope for improved management and quality of life for patients with moderate to severe CHE.
