LEO Pharma Gains FDA sNDA Acceptance for ANZUPGO

Madison, New Jersey, U.S. | April 15, 2026

LEO Pharma has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ANZUPGO® (delgocitinib) cream, seeking to expand its indication to pediatric patients aged 12–17 years with moderate to severe chronic hand eczema (CHE). This regulatory milestone marks a significant advancement in dermatology therapeutics, addressing a major unmet need in pediatric populations where no specifically approved treatments currently exist for chronic hand eczema. The application is supported by positive Phase 3 DELTA TEEN trial data, reinforcing the therapy’s potential to become the first targeted, non-steroidal treatment option for adolescents with CHE.

FDA sNDA Acceptance Advances Pediatric Dermatology Care

The FDA’s acceptance of the sNDA represents a critical step in expanding ANZUPGO’s clinical use beyond adults, where it is already approved for patients with moderate to severe CHE who have inadequate response to topical corticosteroids. This milestone underscores the importance of regulatory pathways in accelerating access to innovative therapies, particularly for underserved pediatric populations.

Chronic hand eczema in adolescents is associated with significant physical discomfort, psychological burden, and disruption to daily activities, highlighting the urgent need for effective and safe treatment options. The FDA review process will evaluate the efficacy, safety, and long-term tolerability of delgocitinib cream in younger patients, potentially setting a new standard of care in pediatric dermatology.

Phase 3 DELTA TEEN Data Demonstrates Strong Clinical Benefit

The sNDA submission is supported by data from the DELTA TEEN Phase 3 clinical trial, a randomized, double-blind, vehicle-controlled study evaluating ANZUPGO in adolescents aged 12–17 years. The trial successfully met its primary endpoint of Investigator’s Global Assessment treatment success, demonstrating significant improvements in disease severity compared to placebo. In addition, key secondary endpoints were achieved, further confirming the therapy’s clinical efficacy and safety profile.

ANZUPGO’s mechanism as a topical pan-Janus kinase (JAK) inhibitor allows it to target inflammatory pathways involved in CHE, offering a non-steroidal alternative with potential for long-term use. These results highlight the therapy’s potential to transform treatment approaches for pediatric patients, where existing options are limited and often associated with safety concerns.

Non-Steroidal Innovation Addresses Unmet Clinical Need

Chronic hand eczema is a persistent inflammatory skin condition characterized by itching, pain, redness, swelling, and skin barrier dysfunction, often leading to reduced quality of life and functional impairment. In pediatric patients, the condition can have a profound impact on social development, education, and daily activities. Traditional treatments, including topical corticosteroids, are often limited by long-term safety concerns and reduced effectiveness, creating a need for alternative therapies.

ANZUPGO addresses this gap by providing a targeted, non-steroidal treatment option that modulates immune signaling pathways, improving both efficacy and tolerability. Its twice-daily topical application and broad usability across disease severities make it a practical solution for long-term disease management.

Strategic Impact on Dermatology and Pharma Innovation

The FDA’s acceptance of the sNDA reinforces LEO Pharma’s commitment to advancing innovative dermatology treatments and expanding access to underserved patient populations. The potential pediatric label expansion builds on existing approvals in multiple global markets, further strengthening the company’s position in the dermatology sector. This milestone also reflects broader industry trends toward targeted therapies, precision medicine, and patient-centric drug development, particularly in chronic inflammatory diseases. By addressing a critical gap in pediatric dermatology, LEO Pharma is contributing to the evolution of next-generation treatment strategies that prioritize safety, efficacy, and long-term patient outcomes.

The FDA acceptance of the ANZUPGO sNDA marks a pivotal step toward improving treatment options for adolescents with chronic hand eczema. With strong Phase 3 clinical data and a novel non-steroidal mechanism of action, ANZUPGO has the potential to become a first-in-class therapy for pediatric CHE, addressing a significant unmet medical need. As the regulatory review progresses, this development highlights the critical role of clinical innovation and regulatory advancement in shaping the future of dermatology and pharmaceutical care, ultimately improving quality of life for patients living with chronic skin conditions.

Source: LEO Pharma press release