FDA Approves LEO Pharma's Delgocitinib for Adults With Moderate to Severe Chronic Hand Eczema

The US FDA announced today the approval of delgocitinib cream (Anzupgo; LEO Pharma Inc.) for adults with moderate to severe chronic hand eczema (CHE) who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable.¹ This makes delgocitinib the first and only FDA-approved treatment for this patient group.

"It is truly exciting that topical delgocitinib is now FDA-approved in the United States for patients suffering from chronic hand eczema," said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, and editor in chief of Dermatology Times, in a statement. "Delgocitinib represents the first approved medication specifically indicated for chronic hand eczema of all subtypes. This is a tremendous win for CHE patients who need a highly efficacious non-steroidal therapy they can use safely."

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Clinical Data

Approval of the steroid-free, topical pan-JAK inhibitor is supported by positive data from the phase 3 DELTA-1 and DELTA-2 clinical trials.² These randomized, double-blind, vehicle-controlled studies enrolled a total of 960 adult patients with CHE to assess the cream’s safety and efficacy over 16 weeks.

The primary measure of success was achieving an Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS)—a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline.

In DELTA 1, 20% of patients treated with delgocitinib reached this endpoint compared to 10% in the vehicle group, while in DELTA 2, 29% of delgocitinib-treated patients achieved success versus just 7% using vehicle cream. Both results were statistically significant, supporting the efficacy of delgocitinib in achieving visible skin improvement.

In addition to meeting the primary endpoints, both studies demonstrated clear benefits on patient-reported symptoms, particularly in 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. Similar improvements were observed in itch, with 47% of patients in both trials experiencing a ≥4-point 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 compared to earlier trials and most events being mild or moderate in nature. The most commonly reported issues were COVID-19 and upper respiratory infections. Tolerability improved over time, and nearly half of previously treated patients maintained IGA-CHE 0/1 responses. More than half of patients who had received placebo in prior trials also achieved significant improvements. Sustained reductions in disease severity scores (HECSI and HESD) were observed, and among those who reinitiated treatment after symptom recurrence, over 80% regained disease control within a median of 8 weeks.

At the 2025 American Academy of Dermatology Annual Meeting, April Armstrong, MD, presented post hoc analysis demonstrating that delgocitinib led to deep, consistent, and durable responses in patients with moderate to severe chronic hand eczema.⁴ About 25% of patients were “super responders,” maintaining ≥75% improvement in itch, pain, or severity through week 16. One-third of patients who achieved clear skin sustained results even after stopping treatment.

Expert Insights

Experts across dermatology and patient advocacy are welcoming the approval of delgocitinib cream as a meaningful step forward for individuals living with chronic hand eczema.

"Its pan-JAK inhibition brings potency and efficacy across all the relevant signaling pathways driving CHE subtypes, and its carefully crafted vehicle minimizes systemic absorption and delivers a safe and tolerable product," Bunick said. "Delgocitinib is a victory for CHE patients because it immediately elevates the standard of care for patients who have long awaited a better quality of life."

Raj Chovatiya, MD, PhD, FAAD, clinical associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois, and a Dermatology Times Editorial Advisory Board member, called the approval a milestone in the evolving landscape of inflammatory skin disease treatment.

"The approval of delgocitinib cream is an exciting milestone in the rapidly evolving therapeutic landscape for inflammatory skin disease. As a topical pan-JAK inhibitor designed to selectively treat the heterogeneous immunologic dysregulation that underlies CHE, delgocitinib is a first-in-class topical therapy that is poised to occupy a critical role in the treatment of CHE patients," Chovatiya told Dermatology Times. "Given that CHE is a complex and heterogeneous condition comprised of multiple etiologic and morphologic subtypes, delgocitinib should ultimately simplify our approach to CHE and offer an efficacious and safe treatment option for patients. Delgocitinib's approval also represents an important acceptance of CHE as a unique disease state in the US, one that is worthy of both individualized care strategies and next generation therapeutic development."

Just ahead of the approval, Dermatology Times Editorial Advisory Board member Adam Friedman, MD, FAAD, said he predicts the approval of delgocitinib will spur even more innovation in the landscape of CHE.

"I think [it] will open the door for more research, but also more investment in rich pipelines that will help us better take care of our patients," Friedman said.

Reflecting on the daily challenges faced by patients, Linda Stein Gold, MD, of Henry Ford Hospital, emphasized the clinical burden of the condition.

"In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of CHE places on patients, and the challenges they face living with it," she said in a news release.¹ "I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms."

From the patient advocacy perspective, the approval represents more than a clinical milestone. It is a long-awaited source of relief and validation.

"We’re thrilled that the FDA recognizes the impact that moderate to severe chronic hand eczema has on patients," said Kristin Belleson, CEO and President of the National Eczema Association.¹ "People living with a debilitating skin disease on their hands find it extremely difficult; it can impact their ability to work, touch, and connect with important people in their lives. The approval of Anzupgo provides hope and promise for the eczema community and those seeking lasting relief from disruptive symptoms."

Regulatory Timeline and Expanding Access

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

"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.¹ "As the first and only FDA-approved treatment for CHE, Anzupgo 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. 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. 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.