FDA Accepts LEO Pharma's Delgocitinib Cream NDA for Chronic Hand Eczema
核心洞察
The FDA has accepted LEO Pharma's New Drug Application (NDA) for delgocitinib cream 2% for treating moderate to severe Chronic Hand Eczema (搜索) (CHE) in adults.
The NDA is supported by Phase 3 DELTA 1 and DELTA 2 clinical trials, which demonstrated the efficacy and safety of delgocitinib cream compared to a cream vehicle.
Delgocitinib cream is an investigational topical pan-JAK inhibitor that addresses the unmet need for CHE patients who have inadequate responses to topical corticosteroids.
LEO Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for delgocitinib cream 20 mg/g (2%) for the treatment of adults with moderate to severe Chronic Hand Eczema (搜索) (CHE). This is for patients who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
This acceptance marks a significant step toward providing a much-needed treatment option for CHE, a condition with currently no FDA-approved therapies. The regulatory review is anticipated to be completed in the second half of 2025.
Clinical Trial Data Supporting Delgocitinib Cream
The NDA submission is based on the results of the Phase 3 DELTA 1 and DELTA 2 clinical trials. These trials evaluated the safety and efficacy of delgocitinib cream compared to a cream vehicle. Both trials met their primary and all secondary endpoints.
The primary endpoint of the DELTA trials was the Investigator’s Global Assessment for Chronic Hand Eczema (搜索) treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.
Key secondary endpoints at Week 16 included a reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline, as well as at least 75% and 90% improvement from baseline on the Hand Eczema Severity Index (HECSI).
Delgocitinib Cream: A Novel Approach
Delgocitinib cream is an investigational topical pan-JAK inhibitor. It works by inhibiting the activation of JAK-STAT (搜索) signaling, which plays a crucial role in the pathogenesis of CHE.
The Burden of Chronic Hand Eczema
CHE is a heterogeneous, fluctuating, inflammatory skin disease characterized by itch and pain. It is associated with skin barrier dysfunction, skin inflammation, and alterations in the skin microbiome. The condition can have a substantial psychological, social, and occupational burden.
Approximately 4.7% of the population suffers from CHE. The condition is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. About 70% of individuals with severe CHE report problems performing everyday activities, significantly impacting their quality of life and mental wellbeing.
LEO Pharma's Commitment
"Our hands are integral to every practical aspect of our lives... I am incredibly proud that LEO Pharma is taking a step towards addressing the long-standing unmet need in CHE for those in the U.S.," said Christophe Bourdon, CEO of LEO Pharma A/S. Brian Hilberdink, EVP and President, Region North America, LEO Pharma, added, "With today’s announcement, we reinforce our commitment to addressing the high unmet need of U.S. patients living with CHE."