JAK Inhibitor Goes Topical: ANZUPGO Approval Signals New GMP Terrain

Leo Pharma Inc. secured FDA approval for ANZUPGO (delgocitinib) on July 23, 2025, marking the entry of a Janus kinase inhibitor into the topical drug space for the first time in the chronic hand eczema (CHE) indication. For manufacturing and quality teams, a topical JAK inhibitor introduces formulation-specific process validation demands and sterility assurance considerations that differ materially from the oral and injectable JAK inhibitor products already on the market.

ANZUPGO is indicated for adults with moderate to severe CHE who have had an inadequate response to topical corticosteroids, or for whom corticosteroids are not advisable. The approval was supported by two randomized, double-blind, vehicle-controlled trials enrolling 960 patients across 99 sites in 10 countries, including Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, and the United Kingdom. Of the 960 enrolled patients, 959 were evaluated for both efficacy and safety. The primary endpoint in both trials was the proportion of patients achieving IGA-CHE treatment success at Week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline. Patients applied the product twice daily to affected areas on the hands and wrists for 16 weeks.

The trial design used the Investigator's Global Assessment for CHE (IGA-CHE) and the Hand Eczema Symptom Diary (HESD) itch score to define and measure disease severity. Enrolled patients had an IGA-CHE score of 3 or 4 and a HESD itch score of 4 or above at baseline. For QA and regulatory leads, the vehicle-controlled design and the 16-week treatment window will be relevant reference points when evaluating comparator product specifications and in-process controls for topical semi-solid manufacturing under 21 CFR Part 211.

Source: FDA Drug Trials Snapshots: ANZUPGO, approved July 23, 2025. Leo Pharma Inc. Full prescribing information should be consulted for all approved conditions of use.