FDA Accepts New Drug Application for Delgocitinib Cream to Treat Chronic Hand Eczema
If approved, delgocitinib cream would be the first US treatment indicated for moderate to severe chronic hand eczema.
The FDA has accepted a new drug application (NDA) for delgocitinib cream (LEO Pharma) 20 mg/g (2%) to treat individuals with moderate to severe chronic hand eczema (CHE) that have experienced inadequate response to topical corticosteroids or were not advised for that form of therapy.1
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CHE is a painful inflammatory, pruritic disease that effects the hand and wrists, impacting the individual’s overall quality of life and occupational abilities. Data displayed that 70% of individuals with severe CHE reported problems in performing everyday activities and a disruption in their daily life due to the condition.1,2
The condition typically persists for more than 3 months or relapses twice or more within a year. The study authors noted that individuals that experience CHE have reported symptoms of itching, pain, erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists. CHE is marked as the most common skin disorder that occurs on the hands with a prevalence rate of 4.7%, according to the news release.1,2
“Dermatologists regularly see the true extent to which CHE impacts patients’ lives through unique physical and psychological challenges,” Christopher Bunick, MD, PhD, associate professor of dermatology at the Yale Medical School, said in a news release. "Many patients need more options beyond traditional topical corticosteroid use, so I welcome today’s news, which brings the prospect of a potential new treatment option one step closer for those across the US living with this debilitating condition.”1
Delgocitinib cream is an investigational topical pan-Janus kinase (JAK) inhibitor that is aimed to treat CHE through the activation of JAK-STAT signaling that plays an essential role in the pathogenesis of CHE. The study authors noted that the submission for the cream was based on findings from the DELTA 1 and DELTA 2 clinical trials that assessed the safety and efficacy of delgocitinib compared to cream vehicle, part of the phase 3 program.1,2
“Our hands are integral to every practical aspect of our lives, from our ability to work, to connecting with loved ones. Today, I am incredibly proud that LEO Pharma is taking a step towards addressing the long-standing unmet need in CHE for those in the US” said Christophe Bourdon, CEO of LEO Pharma A/S, in a news release.1
According to the release, both trials met their primary and al secondary endpoints of treatment success based on the Investigator’s Global Assessment for Chronic Hand Eczema at week 16 and reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline. After week 16 of treatment, individuals were offered to participate in the DELTA 3 open-label, multi-site extension trial to assess the long-term safety of delgocitinib.1
“With today’s announcement, we reinforce our commitment to addressing the high unmet need of U.S. patients living with CHE, a condition that can significantly impact quality of life, including an impact to mental wellbeing,” Brian Hilberdink, EVP and president of region North America at LEO Pharma, said in a news release. “The announcement of the filing of the NDA for delgocitinib cream is a validation of our mission to advance the standard of care, and we are committed to working closely with the FDA in the coming months during its review.”1
