Germany Becomes the First Country to Launch LEO Pharma’s Anzupgo® (delgocitinib) Cream

GLOBAL RELEASE  NOT FOR UK USE – NOT INTENDED FOR UK MEDIA 

BALLERUP, Denmark, October 15, 2024 – LEO Pharma A/S, a global leader in medical dermatology, today 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.¹  The launch makes Germany the first country worldwide where Anzupgo will be available, following the recent European Commission (EC) approval. 

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.² The condition can have a high psychological, social, and occupational burden.^4-6  

“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".  

The European Commission (EC) approval for Anzupgo was based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of Anzupgo compared to cream vehicle.^7-9 Both trials met their primary and all secondary endpoints.^10,11 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.¹²  

"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."   

The launch of Anzupgo in Germany follows the EC decision on September 19th, 2024.  

The EC decision means Anzupgo is now approved in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.¹