FDA Approves Delgocitinib for Moderate to Severe Hand Eczema

With the approval of delgocitinib (Anzupgo; LEO Pharma), the treatment armamentarium for chronic hand eczema has expanded, representing new hope for adult patients with moderate to severe forms of the serious skin disease.¹ The FDA approval is also a novel one, as the steroid-free Janus kinase (JAK) inhibitor is the first and only topical cream specifically targeted to treat moderate to severe chronic hand eczema in adult patients.²

Delgocitinib’s appropriateness in a pediatric population has not been investigated.²

The cream works by blocking JAK1, JAK2, and JAK3, as well as tyrosine kinase 2, significantly hindering the JAK-STAT pathway and suppressing the inflammation and flares that are considered hallmarks of chronic hand eczema.

The approval was based on the global DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) studies, a pair of phase 3 randomized, double-blind, vehicle-controlled 16-week analyses in which 960 patients were evaluated for their response to twice-daily application of either 20-mg/g delgocitinib or cream vehicle.^3,4

“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,” said Robert Spurr, MBA, executive vice president, North America, LEO Pharma, in a statement.¹

DELTA 1 and DELTA 2 had identical primary efficacy end points of Investigator’s Global Assessment for chronic hand eczema treatment success at week 16, which was evaluated on 2 fronts:

• Score of 0 (clear) or 1 (almost clear)
• At least a 2-point improvement from baseline

The overall patient response rates were 20% for delgocitinib vs 10% cream vehicle in DELTA I (P = .006) and 29% vs 7% in DELTA 2 (P < .0001).

Secondary end points were also the same in the trials: itch severity and itch pain, measured by the Hand Eczema Symptom Diary. Data on itch severity were available for 949 patients, and data on itch-related pain were available for 875. By week 16, 49% of patients from each trial had achieved at least a 4-point reduction in their Hand Eczema Symptom Diary pain score compared with 28% of patients who received the vehicle cream in DELTA 1 and 23% in DELTA 2 (P < .0001). Corresponding Hand Eczema Symptom Diary itch score improvements—again, by at least a 4-point drop—were observed in 47% of patients from both trials vs 23% and 20%, respectively, of patients who received the vehicle cream (P < .0001).

Experts highlight the results serving as the basis of this approval are especially promising because of the extreme burden the disease places on patients and considering the psychological, social, and occupational impact on them.¹ Further, patients who completed the 16 weeks of treatment in the original DELTA trials had the option to enroll in DELTA 3 (NCT04949841), the phase 3 longer-term, 36-week open-label extension trial of as-needed treatment with delgocitinib. In this trial, patients once again received a 20-mg/g dose and visited their trial clinic every 4 weeks through week 36, and then at week 38 had a final study evaluation via telephone.⁵ Results through week 52 demonstrated delgocitinib's efficacy, safety, and ability to maintain disease clearance.⁶

Results on rates of adverse events were also promising, with 1% or fewer patients reporting any of the following: application site pain, paresthesia, pruritus, erythema, and bacterial skin infections, including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.

At present, delgocitinib is approved for use and has launched in countries that include Germany, Switzerland, the United Kingdom, and the United Arab Emirates. Its availability in the US is forthcoming. European Commission approval from the European Medicines Agency came on July 25, 2024.⁷

Data show an elevated risk of infection and of nonmelanoma skin cancer with use of delgocitinib, and its use is cautionary in patients who have a recurrent infection, had tuberculosis (TB) or have been in contact with someone with TB, had shingles, had hepatitis B or C, or may have an infection or demonstrate symptoms of an infection.

References

1. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. Business Wire. July 23, 2025. Accessed July 24, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults
2. Anzupgo (delgocitinib). Prescribing information. LEO Pharma; 2025. Accessed July 24, 2025. https://mc-df05ef79-e68e-4c65-8ea2-953494-cdn-endpoint.azureedge.net/-/media/corporatecommunications/us/therapeutic-expertise/our-product/anzupgopi.pdf
3. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1). Clinicaltrials.gov. Updated April 8, 2025. Accessed July 24, 2025. https://clinicaltrials.gov/study/NCT04871711
4. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 2) (DELTA 2). Clinicaltrials.gov. Updated April 8, 2025. Accessed July 24, 2025. https://clinicaltrials.gov/study/NCT04872101
5. Open-label multi-site extension trial in subjects who completed the DELTA 1 or DELTA 2 trials (DELTA 3). Clinicaltrials.gov. Updated April 8, 2025. Accessed July 24, 2025. https://clinicaltrials.gov/study/NCT04949841
6. Santoro C. Chronic hand eczema has significant impacts on patients’ lives, survey reveals. AJMC^®. April 22, 2025. Accessed July 24, 2025. https://www.ajmc.com/view/chronic-hand-eczema-has-significant-impacts-on-patients-lives-survey-reveals
7. Anzupgo (delgocitinib). European Medicines Agency. September 24, 2024. Updated June 18, 2025. Accessed July 24, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo#:~:text=In%20both%20studies%2C%20the%20main,these%20patients%20were%20very%20limited