LEO Pharma's Anzupgo Receives Final European Approval and Market Entry

The European Medicines Agency (EMA) has granted marketing authorization for Anzupgo (delgocitinib), a topical Janus kinase (JAK) inhibitor developed by LEO Pharma. This approval marks a significant regulatory milestone as Anzupgo is the first topical targeted therapy for adult patients with moderate-to-severe chronic hand eczema who have not responded adequately or cannot tolerate conventional topical corticosteroids (TCS). Anzupgo is formulated as a cream for direct application to the skin, designed to minimize systemic side effects while providing potent local immunomodulatory effects. With this decision, LEO Pharma secures exclusive commercialization rights in 31 European countries and is poised to enter a substantial revenue-generating phase.

Efficacy and Safety Demonstrated Through Phase 3 DELTA Trials

The European Commission's (EC) final approval is based on robust clinical data from the DELTA 1 and DELTA 2 global pivotal Phase 3 trials, which involved over 1,000 patients. The clinical results demonstrated that patients treated with Anzupgo achieved a statistically significant improvement in treatment success, defined as complete or almost complete clearance of lesions at Week 16, as assessed by the investigator global assessment (IGA-CHE) score. Furthermore, patients experienced significant improvements in the Hand Eczema Severity Index (HECSI) of 75% and 90%, and a rapid reduction in the severity of pruritus and pain, which are the most bothersome symptoms for patients. Notably, the low systemic absorption of the drug following topical administration mitigates the risk of systemic toxicities associated with oral JAK inhibitors, demonstrating a favorable safety profile.

Addressing Unmet Needs in the Chronic Hand Eczema Market and Competitive Landscape

The global market for chronic hand eczema treatments is estimated at approximately $13.5 billion in 2024, encompassing the seven major countries (United States, four major European countries, United Kingdom, and Japan), and is growing at a robust rate of over 7% annually. This condition has historically been characterized by significant unmet medical needs, with limited treatment options beyond topical steroids, which can cause adverse effects such as skin atrophy. Anzupgo offers a differentiated approach compared to existing systemic therapies, such as AbbVie's Rinvoq and Sanofi's Dupixent, which target atopic dermatitis, by providing the convenience and safety of topical administration. Its unique position as the first topical targeted therapy is expected to drive initial adoption and rapid market penetration in Europe.

Global Rights and Future Expansion into Pediatric Indications

LEO Pharma acquired global development and commercialization rights for delgocitinib, excluding Japan, through a global licensing agreement with Japan Tobacco (2914) in 2014. With the anticipated FDA approval in July 2025 and the recent European market entry, LEO Pharma's global dermatology pipeline has been significantly strengthened. The companies are currently focused on launching the product for adult patients and are also seeking regulatory approval for an expanded indication to include patients aged 12 to 17 years, based on the results of the DELTA Teen clinical trial. Expanding the patient population to include children and adolescents is expected to further maximize market share and solidify long-term revenue growth.