LEO Pharma's Delgocitinib Launches for Chronic Hand Eczema in Germany

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LEO Pharma announced today that the company has launched delgocitinib (Anzupgo) cream in Germany, making it the first country where the topical treatment will be available for adults with moderate to severe chronic hand eczema (CHE).¹

The launch comes less than a month after the European Commission's (EC) approval of delgocitinib in patients matching the above criteria, and in whom prior treatment with topical corticosteroids proved ineffective or inappropriate.² The approval decision applies to all European Union member states, Norway, Iceland, and Liechtenstein.

"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 Urs Kerkmann, MD, PhD, medical director at LEO Pharma Germany, in a news release.¹ "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 EC's approval of delgocitinib was founded on strong outcomes from a phase 3 clinical program, which includes the DELTA 1 and DELTA 2 trials. These double-blind, placebo-controlled studies were designed to evaluate the safety and efficacy of delgocitinib in comparison to a cream vehicle.

Both trials were conducted over a 16-week period and achieved their primary goals, showing significant improvements in clinical symptoms. Additionally, the studies met all secondary endpoints, further reinforcing delgocitinib's therapeutic potential.

Following the completion of the DELTA 1 and DELTA 2 trials, participants were given the opportunity to join the DELTA 3 open-label extension trial, which lasted 36 weeks. This extension phase aimed to monitor the long-term safety and sustained efficacy of delgocitinib in patients who had already completed the initial studies. By providing these extended insights, the DELTA 3 trial helped demonstrate the durable effectiveness of delgocitinib over a longer treatment period.

"[When using delgocitinib on an as-needed basis, over a 36-week period, after the 16-week trial, patients were able to maintain the response over the 36 weeks with IGA clear or almost clear, we saw HECI75 [Hand Eczema Severity Index] responses in half of patients we saw HECSI90 responses in a third of patients and that was maintained throughout the 36 weeks," said Melinda Gooderham, MSc, MD, FRCPC, a dermatologist and clinical researcher from Peterborough, Ontario, Canada, in a previous interview with Dermatology Times describing the outcomes of the DELTA 3 trial.

"What we learned from DELTA 1 and DELTA 2 is that delgocitinib cream is more effective than placebo is safe and tolerated by patients over a 16-week trial," Gooderham said. "One important thing to note is that patients were using this on and off, this was not continuous use. I really feel this mirrors how patients use topical therapy in the real world."

References

1. Germany becomes the first country to launch LEO Pharma’s Anzupgo (delgocitinib) cream. News release. BioSpace. October 15, 2024. Accessed October 15, 2024. https://www.biospace.com/press-releases/germany-becomes-the-first-country-to-launch-leo-pharmas-anzupgo-delgocitinib-cream
2. European Commission approves LEO Pharma’s Anzupgo (delgocitinib) cream for adults with moderate to severe chronic hand eczema (CHE). News release. September 23, 2024. Accessed October 15, 2024. https://www.leo-pharma.com/media-center/news/2024-european-commission-approves-leo-pharma-anzupgo