Delgocitinib (Anzupgo) Scores FDA Approval for Chronic Hand Eczema

The US Food and Drug Administration (FDA) has approved delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema.

Announced by LEO Pharma on July 23, 2025, the approval indicates delgocitinib cream for the topical treatment of chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable based on data from the DELTA 1 and DELTA 2 clinical trials.

“In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of [chronic hand eczema] places on patients, and the challenges they face living with it,” said Linda Stein Gold, MD, Henry Ford Hospital. "I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms.”

DELTA 1 and DELTA 2 were phase 3 randomized, double-blind, vehicle-controlled trials, with a combined enrollment of 960 patients aged 18 years or older. The primary efficacy endpoint in each study was the Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS) at week 16, defined as a score of 0 (clear) or 1 (almost clear) with a 2-point or greater improvement from baseline.

Both studies met all key secondary endpoints. In DELTA 1, 20% of patients treated with delgocitinib achieved IGA-CHE TS compared with 10% of those receiving vehicle (P = .006). In DELTA 2, 29% of patients in the delgocitinib group met this endpoint versus 7% with vehicle (P < .0001).

Using the Hand Eczema Symptom Diary (HESD), 4-point or greater reductions in pain and itch scores were assessed at week 16. In DELTA 1, 49% of delgocitinib-treated patients achieved this threshold for pain vs 28% with vehicle (P < .0001), and in DELTA 2, the corresponding rates were 49% vs 23% (P < .0001). For itch, 47% of delgocitinib patients achieved ≥4-point reduction in both trials compared to 23% and 20% in vehicle arms, respectively (P < .0001 for both).

“[Delgocitinib] is a powerful example of how we transform a real need in the market into medicines that are designed to be ‘easy to use’ and effective for people living with serious skin diseases,” said Christophe Bourdon, chief executive officer of LEO Pharma. “After successfully launching [delgocitinib] in several countries, we’re proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States. The approval of [delgocitinib] reinforces our commitment to investing in difficult-to-treat skin diseases to deliver new treatments to patients where the need is greatest. We’re truly grateful to the patients and physicians who participated in our studies and helped make this approval possible.”

In addition to the pivotal DELTA 1 and DELTA 2 trials, the long-term safety and efficacy of delgocitinib were confirmed in findings from the open-label phase 3 DELTA 3 extension trial (NCT04949841), which enrolled 801 patients who completed DELTA 1 or DELTA 2. Patients received delgocitinib cream twice daily as needed for up to 36 weeks.

In the study, delgocitinib was well tolerated, with the most frequent treatment-emergent adverse events being COVID-19 and nasopharyngitis. Clinical response was sustained among prior delgocitinib-treated patients, with IGA-CHE 0/1 increasing from 24.6% at DELTA 3 baseline to 30.0% at week 36, and Hand Eczema Severity Index (HECSI)-75/90 rates rising from 51.8%/31.8% to 58.6%/36.6%, respectively. Patients initially randomized to vehicle cream in DELTA 1 or 2 showed marked improvement, with IGA-CHE 0/1 rising from 9.1% to 29.5%, and HECSI-75/90 from 23.7%/12.0% to 51.5%/35.7%.

“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, LEO Pharma. “As the first and only FDA-approved treatment for [chronic hand eczema], [delgocitinib] represents an important advance for many patients and further establishes our company's commitment to bringing innovative treatments to market that address unmet needs in medical dermatology.”

References:

1. 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

2. Gooderham M, Molin S, Bissonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. Journal of the American Academy of Dermatology. Published online March 11, 2025. doi: 10.1016/j.jaad.2025.03.008