LEO Pharma Says Anzupgo Launch in Germany Is 'First of Many'

Delgocitinib cream was launched for the first time worldwide in Germany, under the name Anzupgo®, LEO Pharma said in a press release.

The drug was approved in September by the European Commission (EC) for the treatment of adult patients with moderate-to-severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate.

“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,” Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma, said in the press release. “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 EC approval 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. 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.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," Dr. Urs Kerkmann, Medical Director, LEO Pharma Germany, said in the press 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."