EC Approves LEO Pharma’s Anzupgo® Cream for Moderate to Severe Chronic Hand Eczema

LEO Pharma A/S, a prominent name in medical dermatology, has announced that the European Commission (EC) has granted marketing authorization for Anzupgo® (delgocitinib) cream. This approval is specifically for adult patients suffering from moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or not suitable. The EC's decision is effective across all EU Member States, as well as Iceland, Norway, and Liechtenstein. This regulatory milestone comes alongside another significant development: the U.S. FDA has accepted LEO Pharma’s New Drug Application (NDA) for delgocitinib cream.

Christophe Bourdon, CEO of LEO Pharma, expressed the company's commitment to advancing care for skin conditions, stating that the approval of Anzupgo exemplifies their dedication to improving patient outcomes. He emphasized that this new treatment option is eagerly anticipated and that efforts will continue to make Anzupgo accessible to patients in need.

Anzupgo is a topical pan-JAK inhibitor that targets the JAK-STAT signaling pathway, a crucial component in the pathogenesis of CHE. Presently, there are no other topical treatments specifically approved for adults with moderate to severe CHE who cannot use topical corticosteroids. This approval marks a significant step forward in addressing the treatment gap for this patient population.

Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, highlighted that the approval is the result of persistent efforts focused on supporting patients with CHE. He noted the limited treatment options available in Europe and emphasized the debilitating nature of CHE, which the new treatment aims to manage more effectively.

Chronic hand eczema is a diverse and fluctuating inflammatory skin disease, characterized by symptoms such as itching and pain. It is associated with skin barrier dysfunction, inflammation, and microbiome changes. The condition can impose a high psychological, social, and occupational burden on patients.

The EC’s approval of Anzupgo is based on data from phase 3 clinical trials, namely DELTA 1 and DELTA 2, which assessed the safety and efficacy of Anzupgo in comparison to a cream vehicle. Both trials achieved their primary and all secondary endpoints. Patients who completed these 16-week trials were given the option to enroll in a 36-week open-label extension trial (DELTA 3) to further evaluate the long-term safety of Anzupgo.

Anzupgo® (delgocitinib) cream functions as a topical pan-Janus kinase (JAK) inhibitor for treating moderate to severe CHE. By inhibiting the JAK-STAT signaling pathway, it addresses key aspects of CHE pathophysiology, which include skin barrier dysfunction, inflammation, and alterations in the skin microbiome. LEO Pharma holds exclusive worldwide rights to develop and commercialize delgocitinib cream, excluding Japan.

The DELTA 1 and DELTA 2 trials were double-blind, vehicle-controlled, multi-center, phase 3 studies, aimed at evaluating the efficacy of twice-daily applications of Anzupgo. The primary endpoint was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Secondary endpoints included significant reductions in itch and pain scores and improvements on the Hand Eczema Severity Index (HECSI).

Chronic hand eczema (CHE) is defined as hand eczema lasting more than three months or recurring twice or more within a year. Hand eczema is the most common skin disorder of the hands, affecting about 4.7% of the population. In many cases, this condition can become chronic, marked by symptoms such as itching, pain, erythema, scaling, and more. CHE significantly impacts patients' quality of life, daily activities, and even their professional lives.

LEO Pharma, founded in 1908 and majority-owned by the LEO Foundation, is dedicated to advancing dermatological care. With a global team and a diverse range of therapies for various skin conditions, the company generated net sales of DKK 11.4 billion in 2023.