The FDA has accepted for filing a New Drug Application (NDA) from LEO Pharma for delgocitinib cream 20mg/g (2%) for the treatment of adults with moderate to severe Chronic Hand Eczema (CHE), who have had an inadequate response to, or for whom topical corticosteroids are not advisable. The European Commission (EC) has approved delgocitinib cream in the European Union (EU) for CHE.
The regulatory submission for delgocitinib cream, an investigational topical pan-JAK inhibitor, is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle. Both trials met their primary and all secondary endpoints. Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were extended the offer to enroll in the 36-week DELTA 3 open-label extension trial.
The primary endpoint of the DELTA 1 and DELTA 2 trials was the Investigator’s Global Assessment for Chronic Hand Eczema 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. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe).
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