• 17 Oct 2024
• Admin
• News Article

LEO Pharma Launches Anzupgo Cream in Germany to Treat Patients with Chronic Hand Eczema

Overview

LEO Pharma A/S, a global leader in medical dermatology, announces the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. The launch makes Germany the first country worldwide where Anzupgo will be available, following the recent European Commission (EC) approval.

About the Chronic Hand Eczema

• CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain. 
• Its pathophysiology is characterized by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. 
• The condition can have a high psychological, social, and occupational burden.

Statement from the LEO Pharma

• “This significant milestone is a true reflection of LEO Pharma’s commitment to address the unmet need in CHE, a condition that historically has been underappreciated,” said Becki Morison, executive vice president, global product strategy & international operations for LEO Pharma. 
• “Our teams have worked tirelessly to get to this point, and launching Anzupgo in Germany fills me with immense pride. Adults living with moderate to severe CHE in Germany will now have access to a topical treatment specifically approved for their condition. This launch is hopefully the first of many for Anzupgo in the coming months and years ahead, and we are prepared and excited to bring this treatment to more patients."

Trials Behind the EC Approval

• The European Commission (EC) approval for Anzupgo was based on results from the phase 3 programme, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of Anzupgo compared to cream vehicle. 
• Both trials met their primary and all secondary endpoints. 
• Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enroll in the 36-week DELTA 3 open-label extension trial.

Worda from the MD: LEO Pharma Germany

• "Whilst CHE as a disease has a high unmet need and has long been overlooked internationally when it comes to medical research, here in the German population the hand eczema prevalence is high and CHE is a real problem for the patients", said Dr Urs Kerkmann, medical director, LEO Pharma Germany. 
• "Because of this focus in Germany, when I meet dermatologists, many share with me that they have been waiting a long time for new potential treatment options for their CHE patients where topical corticosteroids prove inadequate or inappropriate. I am incredibly excited that today we can do exactly that. Bringing this new treatment option to Germany is a proud moment for the entire team."

About the Launch: - The launch of Anzupgo in Germany follows the EC decision on September 19, 2024.

Anzupgo Approval for All EU States

The EC decision means Anzupgo is now approved in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.

Chronic Hand Eczema: Prevalence

• Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 
• CHE is one of the most common skin disorders of the hands, with a prevalence rate of approximately 4.7%. 
• In a substantial number of patients, HE can develop into a chronic condition. 
• CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.

Che Impact on Quality of Life

• CHE has been shown to cause psychological and functional burdens that impact patient quality of life, with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 
• Furthermore, work and earning potential have also been shown to be impacted by the burden of living with CHE.

About the Cream: Cream Anzupgo

• Cream Anzupgo (delgocitinib) cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. 
• It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE. 
• The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 
• Anzupgo is currently approved in the European Union for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. 
• In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.