Chronic hand eczema (CHE) is referred to as a form of hand eczema (HE) that persists for three months or longer or recurs at least twice within a 12-month period. It is one of the most common skin diseases affecting the hands in many individuals. HE can become a chronic condition. CHE affects approximately one in ten adults worldwide.
Patients may have symptoms like red skin (erythema), scaling and flaking, thickened skin (lichenification), outer skin thickening (hyperkeratosis), fluid-filled blisters (vesicles), edema (swelling), and skin cracks/fissures on their hands and wrists. It is a fluctuating disorder that is characterized by pain and itching. Skin barrier dysregulation, inflammation, and alterations of the skin microbiome are the characteristics of the pathogenesis.
LEO Pharma, a global leader in dermatology, has announced that the US Food and Drug Administration (FDA) approved ANZUPGO® (delgocitinib) cream, 20 mg/g, for topical use in adult patients with moderate-to-severe CHE who are inadequately controlled on topical corticosteroids or for whom it is not recommended to use topical corticosteroids.
ANZUPGO is a novel steroid-free topical treatment and is a pan-Janus kinase (JAK) inhibitor. It affects inflammatory processes by inhibiting the function of the JAK-STAT signalling pathway, specifically inhibiting JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), which contributes to multiple inflammatory processes involved in the initiation and progression of CHE flare-ups.
The FDA’s approval of ANZUPGO marks a significant milestone in LEO Pharma’s initiatives to strengthen its presence in the U.S. market and to drive innovation in dermatologic therapeutics. In preparation for the imminent U.S. launch, LEO Pharma has significantly increased its delivery capacity, with the largest enhancement being a 50% expansion of its sales force.
“ANZUPGO is an example of how we turn unmet clinical needs into new treatments that improve the lives of individuals with severe skin diseases like CHE,” remarked Christophe Bourdon, CEO of LEO Pharma. “We are excited to provide this important treatment solution to U.S. patients living with moderate-to-severe CHE, following successful launches in several international markets. This approval underscores our commitment to invest in solutions for difficult-to-treat skin conditions. We are extremely grateful to the patients and healthcare professionals who contributed to the pivotal clinical trials that made this approval possible.”
CHE is a distressing and often debilitating inflammatory skin condition affecting approximately one in ten adults worldwide. The symptoms of CHE can be both physically uncomfortable and socially embarrassing, and may interfere with daily activities. With the FDA’s approval of ANZUPGO, adults in the U.S. now have access to the first and only product specifically approved to treat moderate-to-severe CHE. This approval also marks the introduction of the first topical pan-JAK inhibitor available in the U.S.
“Dealing with CHE has been extremely challenging for patients, especially for adults, due to the lack of targeted treatment options in the U.S., until now,” said Robert Spurr, Executive Vice President and President of North America at LEO Pharma. “The approval of ANZUPGO as the only FDA-approved treatment for CHE in the nation demonstrates our commitment to meeting unmet needs in medical dermatology.”
This U.S. approval follows previous regulatory milestones for ANZUPGO, including its approval by the European Commission in 2024 and launches in several other countries, including Germany, Switzerland, the United Kingdom, and the United Arab Emirates.
References: LEO. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S..Published July 23, 2025. Accessed July 24, 2025. 2025 FDA approval | LEO Pharma
