Linda Stein Gold, MD, Reacts to Delgocitinib Approval for Chronic Hand Eczema

On July 23, 2025, Leo Pharma announced that the US Food and Drug Administration (FDA) approved delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema in adults.1,2 This marks the first FDA-approved treatment for chronic hand eczema.

The FDA based its decision on data from DELTA 1 and DELTA 2, phase 3 randomized, double-blind, vehicle-controlled trials evaluating delgocitinib in patients aged ≥ 18 years. The primary endpoint was the Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS) at week 16 with ≥ 2-point improvement from baseline.

In DELTA 1, 20% of patients treated with delgocitinib achieved IGA-CHE TS compared with 10% of those receiving vehicle (P = .006). Similarly, in DELTA 2, 29% of patients who received delgocitinib achieved this endpoint compared to 7% with vehicle (P < .0001).

Following this historic approval in the dermatology space, HCPLive spoke with Linda Stein Gold, MD, a dermatologist at Henry Ford Health, on what this approval means for the unmet need in chronic hand eczema.

“For a lot of our patients, it's more moderate or severe, and that means that they have hands that are unable to really work in our everyday needs,” Gold said. “Imagine if your hands are painful and itchy and fissured, you're in a professional setting, and somebody puts out their hand to shake your hand, and you feel humiliated because your hands are maybe red and cracked and bleeding. So not only is it physically uncomfortable, but it's emotionally devastating for our patients, because it really does impact every aspect of their lives.”

She said that household chores—washing dishes or opening jars—can be difficult for these patients. Chronic hand eczema is also common, affecting 10% of adults worldwide. Until now, no FDA-approved treatments existed for moderate to severe chronic hand eczema, which is why many patients received topical corticosteroids.

However, as Gold pointed out, topical corticosteroids are intended for short-term use. Using topical corticosteroids for chronic hand eczema requires repeated application to the skin, but this can lead to local adverse events, such as skin thinning.

Gold believes the approval of delgocitinib is a huge step forward in helping patients, and this space deserves further development.

“We might see new drugs on the horizon in the future, but I think what doctors are looking for ideally is something that's topical,” Gold said. “Ideally, we like to use something that gets right at the heart of the disease, something that doesn't have systemic complications. If we can manage this with topical therapy safely and effectively, that's really a win-win for our patients as well as our prescribers. We'll see what the future holds.”

References

1. Campbell, P. Delgocitinib (Anzupgo) Scores FDA Approval for Chronic Hand Eczema. HCPLive. July 23, 2025. https://www.hcplive.com/view/delgocitinib-anzupgo-fda-approved-for-chronic-hand-eczema. Accessed July 24, 2025.

2. LEO Pharma. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S. LEO Pharma. Published July 23, 2025. Accessed July 23, 2025. https://www.leo-pharma.com/media-center/news/2025-fda-approval