FDA accepts NDA for delgocitinib cream 20 mg/g (2%) to treat moderate to severe hand eczema
LEO Pharma Inc. announced that the FDA has accepted for filing a NDA for delgocitinib cream 20 mg/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
This marks an important next step on LEO Pharma’s path to providing delgocitinib cream to adults living with moderate to severe CHE, a condition for which there are currently no FDA approved treatments. This news is the latest in a series of regulatory milestones globally. Today LEO Pharma also announced the European Commission (EC) approval for delgocitinib cream in the European Union (EU).
The regulatory submission for delgocitinib cream is based on results from the phase III 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.
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