BALLERUP, DENMARK -- LEO Pharma, a global leader in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has approved ANZUPGO® (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.[1]

ANZUPGO is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE.[1] ANZUPGO inhibits the JAK-STAT pathway, specifically blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), and suppresses the various inflammatory responses that play a key role in the onset and subsequent flares of CHE.[1], [2], [4]

The FDA approval of ANZUPGO marks a significant milestone in LEO Pharma’s strategy to expand its presence in the U.S. market and deliver purposeful innovation in skin health. In preparation for bringing ANZUPGO to the U.S. patients, LEO Pharma has significantly upscaled its operations across key functions - including a 50% increase in the sales force.

“ANZUPGO is a good example of how we transform a real need in the market into medicines that can help make a difference for people living with serious skin diseases such as CHE,” said Christophe Bourdon, CEO, LEO Pharma. “After successfully launching ANZUPGO in several countries, we’re proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States. The approval of ANZUPGO reinforces our commitment to investing in difficult-to-treat skin conditions to deliver new treatments to patients where the need is greatest. We’re truly grateful to the patients and physicians who participated in our studies and helped make this approval possible.”

CHE is a highly debilitating inflammatory skin disease that affects approximately one in ten adults worldwide, causing itchy, painful, blistered, or swollen skin that can interfere with daily activities.[2], [3], [5], [6] The FDA approval of ANZUPGO provides adults in the U.S. living with moderate-to-severe CHE with the first and only treatment option specifically approved for this skin disease, just as it will be the first and only topical pan-JAK-inhibitor on the U.S. market.

“Chronic hand eczema can be a very difficult disease for adults to manage, especially given the lack of treatment options in the U.S. until now,” said Robert Spurr, EVP and President, North America, LEO Pharma. “As the first and only FDA-approved treatment specifically for CHE in the U.S., ANZUPGO further establishes our company’s real commitment to bringing treatments to market that address unmet needs in medical dermatology.”

The FDA approval is the latest regulatory milestone for ANZUPGO, following the European Commission (EC) approval in 2024 and several launches internationally, including Germany, Switzerland, the United Kingdom and the United Arab Emirates.