LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema

The FDA approved LEO Pharma's Anzupgo (delgocitinib), making it the first and only treatment specifically approved in the U.S. for moderate-to-severe chronic hand eczema (CHE) in adults1345.

Anzupgo is also the first topical pan-JAK inhibitor on the U.S. market, distinguishing it from other therapies by blocking several JAK enzymes (JAK1, JAK2, JAK3, and TYK2) to suppress inflammatory responses that drive CHE13.

The clinical trials DELTA 1 and DELTA 2 demonstrated that delgocitinib provided significant improvement over placebo:
20–29% of patients achieved treatment success versus 7–10% with vehicle at week 164.

CHE is a highly debilitating, recurrent skin disease that interferes with daily life for about 10% of adults worldwide, causing itchy, painful, blistered, or swollen skin13.

LEO Pharma acquired the rights to delgocitinib outside Japan (where it is already marketed) and scaled up its U.S. operations—including a 50% sales-force increase—in preparation for the launch13.

Anzupgo fills an unmet need:
prior to this approval, no treatment had an FDA indication specifically for CHE234.

The price of Anzupgo in the U.S. has not yet been disclosed by LEO Pharma1.

Sources:

1. https://www.fiercepharma.com/pharma/leo-roars-key-fda-nod-anzupgo-treat-chronic-hand-eczema

2. https://www.webmd.com/skin-problems-and-treatments/eczema/news/20250724/fda-oks-new-steroid-free-skin-cream-for-hand-eczema

3. https://www.leo-pharma.com/media-center/news/2025-fda-approval

4. https://www.hcplive.com/view/linda-stein-gold-md-reacts-to-delgocitinib-approval-for-chronic-hand-eczema

5. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults