FDA

Anzupgo cream OK’d for chronic hand eczema

July 28, 2025

Brand name: Anzupgo

Generic name: delgocitinib

Manufacturer: Leo Pharma

Approval date: July 23, 2025

FDA approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who’ve had an inadequate response to, or for whom topical corticosteroids aren't advisable.

According to a manufacturer press release, Anzupgo is a steroid-free, topical pan-Janus kinase (JAK) inhibitor that targets 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.

Efficacy

Approval was based on data from 2 randomized, double-blind, phase 3 trials: DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101). The trials enrolled a total of 960 adult participants with moderate to severe CHE who had a history of inadequate response to, or for whom topical corticosteroids were not advisable. All participants who completed TRIAL 1 and TRIAL 2 were eligible to enroll into a long-term extension trial (DELTA 3 [NCT04949841]).

In both trials, subjects applied either topical Anzupgo or vehicle twice daily to affected areas on the hands and wrists for 16 weeks. The primary efficacy endpoint was the proportion of participants who achieved Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) treatment success (IGA-CHE TS) at Week 16, defined as a score of 0 (clear) or 1 (almost clear) with ≥2-point improvement from baseline.

In the DELTA 1 trial, 20% of patients treated with delgocitinib achieved IGA-CHE TS vs. 10% of those receiving vehicle (difference, 10%; 95% confidence interval [CI], 4-16; P=.006). In DELTA 2, 29% vs. 7% of participants achieved IGA-CHE TS in the delgocitinib and vehicle arms, respectively (difference, 22%; 95% CI, 16-29; P <.0001).

In addition, a statistically significantly higher proportion of patients treated with delgocitinib vs. vehicle had an improvement in Hand Eczema Symptom Diary (HESD) itch score by ≥4 points (DELTA 1: difference, 24%; 95% CI, 16-33; and DELTA 2: difference, 27%; 95% CI, 19-36), as well as an improvement in HESD pain score by ≥4 points (DELTA 1: difference, 22%; 95% CI, 12-31; and DELTA 2: difference, 26%; 95% CI, 17-35).

Safety

Adverse reactions that were reported in ≤1% of trial participants were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.

Sources:

LEO Pharma announces FDA approval of Anzupgo® (delgocitinib) Cream in the US. [News release]. 2025. https://www.leo-pharma.com/media-center/news/2025-fda-approval

Anzupgo (delgocitinib) [package insert]. Leo Pharma. https://mc-df05ef79-e68e-4c65-8ea2-953494-cdn-endpoint.azureedge.net/-/media/corporatecommunications/us/therapeutic-expertise/our-product/anzupgopi.pdf Revised July 2025. Accessed July 25, 2025.