FDA accepts sNDA for delgocitinib in adolescents with chronic hand eczema

The FDA has accepted a supplemental new drug application (sNDA) for delgocitinib (Anzupgo; LEO Pharma Inc) for treating moderate to severe chronic hand eczema (CHE) in pediatric patients aged 12 to 17 years, according to LEO Pharma Inc.¹

Currently, delgocitinib is FDA approved for treating severe CHE in adults when topical corticosteroids lead to an inadequate response or are not advisable. Expanding the label for this topical and nonsteroidal pan–Janus kinase (JAK) inhibitor would build on existing approvals and help the treatment reach underserved patient populations.

“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,” said Sophie Lamle, executive vice president, development, at LEO Pharma.

Phase 3 DELTA TEEN trial supports application

The sNDA is supported by data from the phase 3, randomized, double-blind DELTA TEEN trial indicating positive safety and efficacy results for delgocitinib 20 mg/g cream in pediatric patients aged 12 to 17 years with severe CHE. Topical corticosteroids were deemed inadequate or inappropriate in the study population.

Treatment success at week 16 was reported as the primary endpoint of the trial, defined as an Investigator’s Global Assessment for chronic hand eczema treatment success score of 0 or 1 and at least a 2-step improvement from baseline. A score of 0 indicated clear, while a score of 1 indicated almost clear.

Delgocitinib 20 mg/g was compared to cream vehicle and met the trial’s primary and key secondary end points. These results were presented at the 2025 European Academy of Dermatology and Venereology Congress in Paris, France.

Clinical burden and symptoms

CHE is one of the most common skin diseases of the hands and wrists, defined as hand eczema lasting more than 3 months or relapsing twice or more in 1 year. Symptoms include itch and pain, erythema, scaling, hyperkeratosis, lichenification, edema, vesicles, and fissures on hands and wrists.

Patients with CHE often experience psychological and functional burdens influencing their quality of life. Issues performing everyday activities have been reported by 70% of individuals with the condition. As a nonsteroidal pan-JAK inhibitor, delgocitinib can inhibit JAK-STAT signaling activation, which plays a vital role in CHE pathogenesis.

“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,” said Lamle.

Importance of assessing sleep in pediatric eczema

Effective eczema treatments are needed to prevent adverse quality of life impacts. These include sleep disruptions, which were highlighted in eczema patients by Druhan L. Howell, MD, Organon health partner, in an interview with Contemporary Pediatrics.²

According to Howell, clinicians need to look beyond visible skin symptoms when providing pediatric care to patients with eczema. They should ask details questions about sleep quality, including how frequently a child wakes during the night, difficulty falling asleep, and how disrupted sleep impacts daytime functioning.

Outcomes of eczema-related sleep disruption include behavioral changes, irritability, school performance changes, and parental work impairment. This burden may be measured using validated tools such as the Patient-Oriented Eczema Measure and the Dermatitis Family Impact questionnaire.

“This is a way to allow the clinicians themselves to have more of a well-rounded view and objective data on how the eczema is impacting their lives,” said Howell.

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. April 15, 2026. Accessed April 15, 2026. https://www.businesswire.com/news/home/20260415666395/en/LEO-Pharma-Announces-FDA-Acceptance-of-Supplemental-NDA-for-ANZUPGO-delgocitinib-Cream-for-the-Treatment-of-Chronic-Hand-Eczema-in-Children-Aged-12-17
2. Howell D. Druhan L. Howell, MD, addresses sleep disruption in atopic dermatitis. Contemporary Pediatrics. February 27, 2026. Accessed April 15, 2026. https://www.contemporarypediatrics.com/view/druhan-l-howell-md-addresses-sleep-disruption-in-atopic-dermatitis