FDA Greenlights First Treatment for Chronic Hand Eczema in Adults
Key Takeaways
The FDA has approved ANZUPGO® (delgocitinib) cream as the first treatment for adults with moderate-to-severe chronic hand eczema (CHE).
The approval is driven by positive results from from the DELTA 1 and DELTA 2 studies, showing significant improvements in skin clearance, itch, and pain.
The US Food and Drug Administration (FDA) has approved ANZUPGO® (delgocitinib) cream, making it the first and only treatment approved for adults with moderate-to-severe chronic hand eczema (CHE) who are unresponsive to topical corticosteroids or for those unsuitable for treatment.
“Chronic hand eczema can be a very difficult disease for adults to manage with no approved treatment options until now,” said Robert Spurr, Executive Vice President, North America at LEO Pharma, in the press release. “As the first and only FDA-approved treatment for CHE, ANZUPGO represents an important advance.”
According to a press release from the manufacturer, the approval is based on results from two identically designed phase 3 studies (DELTA 1 and DELTA 2) that included 960 adults with moderate-to-severe CHE. The primary endpoint was achievement of treatment success as measured by the Investigator’s Global Assessment for CHE (IGA-CHE TS) at 16 weeks, defined as clear or almost clear skin with at least a two-grade improvement from baseline.
In DELTA 1, 20% of patients receiving ANZUPGO achieved treatment success vs. 10% with vehicle (P = 0.006), while DELTA 2 reported 29% success in the treatment arm vs. 7% with vehicle (P < 0.0001). Both trials met all key secondary endpoints, including reductions in Hand Eczema Symptom Diary (HESD) scores for itch and pain. The treatment also had an acceptable safety profile. Adverse events occurred in 1% or fewer of patients.
“This new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms,” said Linda Stein Gold, MD, of Henry Ford Hospital, in a press release.
Source: LEO press release. July 24, 2025.