BioPharma, Pharma

LEO Pharma Topical Cream Is Now the First FDA-Approved Drug for Chronic Hand Eczema

Chronic hand eczema, which can develop from chemicals and cleansers that people use frequently for work, now has its first FDA-approved treatment. The new LEO Pharma drug, Anzupgo, is a topical cream designed to block four signaling proteins that drive inflammation.

By Frank Vinluan on July 24, 2025 1:42 pm

A chronic form of eczema that develops specifically in the hands now has its first approved FDA-approved drug, a topical cream from dermatological medicines specialist LEO Pharma.

The Wednesday regulatory decision for the LEO drug, delgocitinib, covers the treatment of moderate-to-severe chronic hand eczema in adults whose disease has not responded adequately to topical steroids. It also includes those who cannot take topical steroids. Denmark-based LEO will market its new product under the brand name Anzupgo.

Eczema, also known as atopic dermatitis, is an immunological disorder that shows itself as red patches and scaly skin that itches and sometimes blisters. Hand eczema, also called hand dermatitis, is often triggered by irritants that people encounter in their jobs. Cleansers or chemicals used in cleaning, hairdressing, and mechanical work can lead to hand eczema. Chronic hand eczema is defined as hand eczema that lasts for three months or relapses twice or more within a year.

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Topical steroids and emollients are standard treatments for chronic hand eczema, but these products usually have limited efficacy. Anzupgo works by blocking the JAK-STAT pathway, a signaling pathway that plays a role in immune responses. The non-steroidal topical cream, applied twice daily, suppresses inflammatory responses by blocking four proteins in the pathway: JAK1, JAK2, JAK3, and TYK2.

LEO evaluated Anzupgo in two pivotal clinical trials that compared the study drug to an inert cream. The main goal was was to show clear or almost clear skin at week 16. Both studies met that mark with statistically significant results. The studies also met secondary goals measuring pain and itch reduction.

Oral JAK inhibitors carry a class-wide black box warning for risks that include cancer and cardiovascular problems. But those drugs, taken as pills, circulate throughout the body. As a topical drug, Anzupgo’s effects are not expected to go beyond the skin. Adverse reactions reported in clinical studies include application site pain, sensations of tingling and numbness, itching, and a reaction leading to skin redness. Anzupgo’s label does not carry a black box warning.

Anzupgo was initially developed by Japan Tobacco (JT). In 2017, LEO licensed rights to develop the drug globally, except for Japan, where JT retains rights. The product was approved by the European Commission last year. It’s also approved in Switzerland, the United Kingdom, and the United Arab Emirates.

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Privately held LEO already has a presence in eczema with Adbry, an antibody designed to block the signaling protein IL-13. Adbry, approved in 2022, is administered as an injection every other week. LEO said Anzupgo contributes to its strategy of expanding its U.S. presence.

“As the first and only FDA-approved treatment for [chronic hand eczema], 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,” Robert Spurr, LEO’s executive vice president, North America, said in a prepared statement.

Photo by LEO Pharma