A New Era In Skin Care: LEO Pharma’s Anzupgo® Cream Launches In Germany

LEO Pharma A/S, a leading name in medical dermatology, proudly introduces Anzupgo® (delgocitinib) cream in Germany, specifically designed for adults suffering from moderate to severe Chronic Hand Eczema (CHE) who find topical corticosteroids ineffective or unsuitable. This marks Germany as the first country in the world to offer Anzupgo, following its recent approval by the European Commission.

Chronic Hand Eczema is a complex and variable inflammatory skin condition that primarily causes itching and discomfort. Its underlying causes include compromised skin barrier function, inflammation, and changes in the skin microbiome. The impact of CHE extends beyond physical symptoms, significantly affecting patients' psychological, social, and professional lives.

Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma, stated, “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. 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".

Dr Urs Kerkmann, Medical Director, LEO Pharma Germany, mentioned, "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. 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.”

The approval of Anzupgo by the European Commission (EC) was supported by findings from the phase 3 clinical program, encompassing the DELTA 1 and DELTA 2 trials. These studies assessed the safety and effectiveness of Anzupgo in comparison to a placebo cream. Both trials successfully achieved their primary and all secondary objectives. Participants who completed the 16-week DELTA 1 or DELTA 2 studies were subsequently invited to take part in the 36-week DELTA 3 open-label extension trial.

Anzupgo's introduction in Germany comes after the European Commission's decision on September 19, 2024. This approval allows Anzupgo to be available in all EU member states, as well as in Iceland, Norway, and Liechtenstein. Efforts to secure regulatory approvals in additional markets are currently in progress.