FDA Approves ANZUPGO® Cream by LEO Pharma in U.S.

BALLERUP, Denmark, July 23, 2025 – LEO Pharma, a prominent name in the field of medical dermatology, has announced that the U.S. Food and Drug Administration (FDA) has given its approval to ANZUPGO® (delgocitinib) cream. This topical treatment is designed for adults suffering from moderate-to-severe chronic hand eczema (CHE) who have not responded adequately to topical corticosteroids or for whom such treatments are deemed unsuitable. ANZUPGO represents a groundbreaking option, being a steroid-free, topical pan-Janus kinase (JAK) inhibitor specifically targeting adults with this condition. It works by inhibiting the JAK-STAT pathway, thereby suppressing the inflammatory reactions that contribute to the development and exacerbation of CHE.

The FDA's approval of ANZUPGO signifies a crucial advancement in LEO Pharma's objectives to expand its reach within the U.S. and innovate in the area of dermatological health. To facilitate the introduction of ANZUPGO to American patients, LEO Pharma has significantly bolstered its operational capabilities, which includes a substantial 50% increase in its sales personnel.

Christophe Bourdon, CEO of LEO Pharma, highlighted that ANZUPGO exemplifies the company’s dedication to transforming significant market needs into medicinal solutions that can profoundly impact those living with severe skin conditions like CHE. “Following successful launches in multiple countries, we are thrilled to present this innovation to adults in the United States with moderate-to-severe CHE. The approval underscores our commitment to investing in challenging-to-treat skin conditions, ensuring patients have access to novel therapies where the need is most urgent. We express our gratitude to the patients and clinicians who participated in our research and contributed to this achievement,” Bourdon stated.

Chronic hand eczema is a severely debilitating inflammatory condition affecting about 10% of adults globally. It results in persistent itching, pain, blistering, or swelling of the skin, which can severely hinder daily functions. With the FDA's approval, adults in the U.S. with moderate-to-severe CHE now have access to the first and only treatment specifically sanctioned for this condition, making ANZUPGO the sole topical pan-JAK inhibitor available in the U.S. market.

Robert Spurr, Executive Vice President and President of North America at LEO Pharma, remarked, “Managing chronic hand eczema can be particularly challenging for adults, especially given the previous lack of available treatments in the U.S. Now, as the first and only FDA-sanctioned treatment for CHE in the U.S., ANZUPGO reaffirms our company's commitment to addressing unmet needs within medical dermatology.”

This FDA approval is a continuation of ANZUPGO's successful regulatory journey, following its earlier approval by the European Commission in 2024 and subsequent launches in several countries, including Germany, Switzerland, the United Kingdom, and the United Arab Emirates.

ANZUPGO cream is specifically tailored for adults with moderate-to-severe chronic hand eczema, acting as a topical pan-Janus kinase inhibitor by blocking the JAK-STAT signaling pivotal in the disease's pathogenesis. Since 2014, LEO Pharma has held exclusive global rights (excluding Japan) to develop and market delgocitinib, following an agreement with Japan Tobacco Inc. The full prescribing and medication information for ANZUPGO can be found on the LEO Pharma website.

Chronic hand eczema is characterized by symptoms such as itching, pain, redness, and scaling, impacting patients’ quality of life and daily function. It is a recurrent condition, often leading to psychological and functional burdens, and can significantly affect one’s career and earning potential.

LEO Pharma, headquartered in Denmark, stands as a global leader in the domain of medical dermatology, committed to providing innovative skin health solutions. The company prides itself on a rich legacy in healthcare and serves nearly 100 million patients across over 70 countries annually, with a dedicated team of 4,000 employees worldwide.