LEO Pharma is launching delgocitinib cream (Anzupgo) in Germany for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.
Germany is the first country worldwide where delgocitinib cream will be available, following the recent European Commission (EC) approval. The EC decision means Anzupgo is now approved in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway,
The EC approval for delgocitinib cream 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 delgocitinib cream compared to cream vehicle. Both trials met their primary and all secondary endpoints.1 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
“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”, says Dr, Urs Kerkmann, Medical Director of LEO Pharma Germany, in a news release. “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.”
VIDEO EXTRA: Reviewing the Data: Delgocitinib Cream for Chronic Hand Eczema
George Martin, MD, Founder of Maui Derm, and Ted Rosen, MD, a Professor of Dermatology at Baylor College of Medicine in Houston, TX, discuss the data supporting the use of delgocitinib cream (Leo Pharma) for the treatment of chronic hand eczema.
