New Option for Chronic Hand Eczema Gets FDA Green Light: Daily Dose

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Last week, we reported on the US FDA approval of delgocitinib (Anzupgo) 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.

The approval

The approval maked delgocitinib the first treatment specifically indicated by the FDA for CHE.

The agency based its acceptance of the regulatory submission on review of findings from the multicenter, randomized, double-blind, vehicle-controlled phase 3 DELTA 1 and DELTA 2 clinical trials. The studies evaluated the safety and efficacy of delgocitinib 2% applied twice daily compared with a cream vehicle in adults with moderate-to-severe CHE over a 16-week treatment period. Both of the trials met their primary and all secondary endpoints.

In DELTA 1, 20% of study participants treated with delgocitinib met the study’s primary endpoint, Investigator’s Global Assessment for Chronic Hand Eczema treatment success score of of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline compared with 10% of those using cream vehicle. In DELTA 2, 29% of those treated with the active study drug achieved IGA-CHE TS vs 7% of the placebo-treated group. The 2 studies also demonstrated significant benefits on patient-reported outcomes, most notably reducing pain and itch.

Delgocitinib is a steroid-free, topical pan-Janus kinase (JAK) inhibitor that targets JAK1, JAK2, JAK3, and TYK2, suppressing the inflammatory responses central to CHE pathophysiology.

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