FDA Approves Delgocitinib, First Treatment for Adults with Moderate to Severe Chronic Hand Eczema

The FDA on Wednesday approved delgocitinib (Anzupgo) cream 20 mg/g for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable, according to LEO Pharma. This approval makes delgocitinib the first treatment specifically indicated by the FDA for CHE, a condition that affects approximately 1 in 10 adults worldwide.

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Delgocitinib is a steroid-free, topical pan-Janus kinase (JAK) inhibitor that targets JAK1, JAK2, JAK3, and TYK2, suppressing the inflammatory responses central to CHE pathophysiology. The drug inhibits the JAK-STAT pathway, a key driver of disease flares and chronic inflammation in this condition.

The agency based its acceptance of the regulatory submission on review of findings from the multicenter, randomized, double-blind, vehicle-controlled phase 3 DELTA 1 and DELTA 2 clinical trials. The studies evaluated the safety and efficacy of delgocitinib 2% applied twice daily compared with a cream vehicle in adults with moderate-to-severe CHE over a 16-week treatment period. Both of the trials met their primary and all secondary endpoints.3,4

In DELTA 1, 20% of study participants treated with delgocitinib met the study’s primary endpoint, Investigator’s Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) score of of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline compared with 10% of those using cream vehicle. In DELTA 2, 29% of those treated with the active study drug achieved IGA-CHE TS vs 7% of the placebo-treated group.3,4

Participants who completed 16 weeks of treatment with either delgocitinib or placebo in either trial were eligible to continue in the 36-week open label DELTA 3 extension trial.3

The 2 studies also demonstrated significant benefits on patient-reported outcomes, most notably reducing pain and itch. Using the Hand Eczema Symptom Diary (HESD), researchers measured symptom severity at baseline and again at week 16. Nearly half of the delgocitinib-treated patients in both studies reported at least a 4-point drop in pain scores—49% in DELTA 1 and 49% in DELTA 2—compared to only 28% and 23%, respectively, in the vehicle groups. Improvement reported in pruritis were similar, with 47% of patients in both trials experiencing a 4-point or greater reduction, versus 23% and 20% for those using vehicle cream.

Additional data on delgocitinib from the DELTA-3 (NCT04949841) open-label extension trial3 highlights a favorable safety profile, with no increase in adverse events (AEs) compared to earlier trials. Most events were mild or moderate in severity. The AEs more commonly reported were COVID-19 and upper respiratory infections. Tolerability improved over time, and nearly half of previously treated patients maintained IGA-CHE 0/1 responses.

Late breaking data on delgocitinib cream presented at the American Academy of Dermatology Annual Meeting highlighted treatment response to the topical pan-Janus kinase (JAK)-inhibitor in a subgroup of "super responders" from DELTA 1 and DELTA 2 who exhibited a deep, consistent and durable response to the novel cream. Approximately one-quarter of participants were identified as super responders, maintaining a 75% or greater improvement in itch, pain, or severity through week 16. One-third of patients who achieved clear skin sustained results even after stopping treatment.

“Chronic hand eczema can be a very difficult disease for adults to manage, especially given the lack of treatment options in the US until now,” Robert Spurr, Leo Pharma executive vice president and president, North America, said in the company announcement. “As the first and only FDA-approved treatment specifically for CHE in the US, [delgocitinib] further establishes our company's real commitment to bringing treatments to market that address unmet needs in medical dermatology.”

CHE is a chronic inflammatory skin disease characterized by erythema, scaling, vesicles, lichenification, and fissures. It can present with pain, itch, blistering, or swelling, and it is frequently associated with functional impairment. In approximately 70% of individuals with severe CHE, the condition interferes with daily activities. Psychological burden, work productivity loss, and reduced quality of life are well-documented consequences of the disease.

The US FDA approval of delgocitinib follows earlier international regulatory approvals, including European Commission approval in 20245 and launches in Germany, the United Kingdom, and the United Arab Emirates.

Full prescribing information is available at: https://www.leo-pharma.us/AnzupgoPI

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. LEO Pharma Inc. July 23, 2025. Accessed July 23, 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. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4
3. 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. J Am Acad Dermatol. Published online March 11, 2025. doi:10.1016/j.jaad.2025.03.008
4. Halsey G. Delgocitinib Data Reveal "Super Responders" in CHE During AAD 2025 Late Breaker. Patient Care. March 10, 2025. https://www.patientcareonline.com/view/delgocitinib-data-reveals-super-responders-in-che-during-aad-2025-late-breaker
5. Armstrong A. “Super responders” following treatment with delgocitinib cream 20mg/g in a subgroup of patients with moderate to severe chronic hand eczema. Poster presented at: 2025 American Academy of Dermatology Annual Meeting. March 7-11, 2025; Orlando FL.