FDA Accepts sNDA for Delgocitinib Cream to Treat Pediatric Chronic Hand Eczema

Today, LEO Pharma has announced that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for delgocitinib cream) (ANZUPGO) as a treatment for moderate to severe chronic hand eczema (CHE) in pediatric patients aged 12 to 17.¹ The regulatory milestone marks a significant step toward potentially expanding the indication of this topical, non-steroidal pan–Janus kinase (JAK) inhibitor to an underserved population for whom no FDA-approved, disease-specific therapies currently exist.

“Pediatric patients living with chronic hand eczema currently have no approved treatment options specifically indicated for CHE, representing a significant unmet medical need,” said Bob Spurr, EVP and President, Region North America at LEO Pharma. “As LEO Pharma continues to expand its presence in the U.S., we are committed to investing in the development and advancement of treatments like ANZUPGO, which is the only approved treatment specifically for chronic hand eczema in adults and, if approved for pediatric patients, could help address this important gap in care.”¹

Clinical Evidence: The DELTA TEEN Trial

The application is supported by data from the pivotal phase 3 DELTA TEEN trial, a 16-week, randomized, double-blind, vehicle-controlled, multicenter study evaluating twice-daily delgocitinib cream in 98 patients aged 12 to 17 years with moderate to severe CHE. All enrolled participants had disease that was inadequately controlled with, or inappropriate for, topical corticosteroids. The study met its primary endpoint, defined as treatment success based on the Investigator’s Global Assessment for CHE (IGA-CHE), with patients achieving clear or almost clear skin (scores of 0 or 1) and at least a two-grade improvement from baseline at week 16. Key secondary endpoints, including ≥90% improvement in the Hand Eczema Severity Index (HECSI-90) and improvements in Hand Eczema Symptom Diary (HESD) scores, were also met. Detailed results were previously presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.²

The Unmet Need in Pediatric CHE

CHE in pediatric populations represents a notable unmet clinical need. Although CHE is well characterized in adults, pediatric-specific treatment guidelines are lacking, and therapeutic options are limited. The chronic burden is further compounded by the limitations of long-term topical corticosteroid use, including concerns about skin atrophy and other adverse effects with repeated or prolonged application.

“Currently, there are no approved therapies, neither EMA nor FDA, for adolescents with chronic hand eczema," said Alexander Egeberg, MD, PhD, professor of dermatology and the global head of medical affairs at LEO Pharma, in a previous interview with Dermatology Times. "As a clinician, I can tell you that this population does have a high unmet need. If approved, this will really be a promising option."

Delgocitinib’s mechanism of action involves inhibition of the JAK-STAT signaling pathway, which plays a central role in inflammatory and immune-mediated processes underlying CHE. As a pan-JAK inhibitor formulated for topical use, delgocitinib offers a targeted, non-steroidal approach that may help address both efficacy and tolerability challenges associated with existing therapies. This is particularly relevant in pediatric patients, where long-term safety considerations are paramount.

Regulatory Status and Global Reach

Delgocitinib was approved by the FDA in July 2025 for adults with moderate to severe CHE who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable.³ The therapy is authorized in the European Union, the United Kingdom, and other markets, with regulatory review for adolescent use also ongoing with the European Medicines Agency.

“We are incredibly excited to have taken this step in hopefully providing a new treatment for pediatric patients currently lacking options specifically indicated for CHE in the US,” said Sophie Lamle, Executive Vice President of Development at LEO. “For pediatric patients living with chronic hand eczema, the disease can affect them at a formative time in their lives and personal development. The FDA’s acceptance to review this filing brings us one step closer to potentially offering a much-needed treatment option for this underserved population.”¹

References

1. LEO Pharma announces FDA Acceptance of supplemental NDA for ANZUPGO® (delgocitinib) cream for the treatment of Chronic Hand Eczema in children aged 12-17. News release. LEO Pharma Inc. Published April 15, 2026. Accessed April 15, 2026. https://www.leo-pharma.com/media-center/news/2026-acceptance-of-anzupgo-snda

2. LEO Pharma presents late-breaking phase 3 delgocitinib cream data in adolescents with moderate to severe chronic hand eczema (CHE). News release. Business Wire. Published September 18, 2025. Accessed April 15, 2026. https://www.businesswire.com/news/home/20250918307792/en/LEO-Pharma-Presents-Late-Breaking-Phase-3-Delgocitinib-Cream-Data-in-Adolescents-with-Moderate-to-Severe-Chronic-Hand-Eczema-CHE

3. 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. Published July 23, 2025. Accessed April 15, 2026. 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