FDA Accepts NDA for Delgocitinib Cream Treatment of Chronic Hand Eczema

Today, an announcement by LEO Pharma noted that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for delgocitinib cream for chronic hand eczema (CHE).¹

If the medication is approved following the accepted filing, delgocitinib cream would be the first moderate to severe CHE treatment approved within the US for adults patients. The topical cream is an investigational pan-Janus kinase (JAK) inhibitor which specifically inhibits the activation of JAK-STAT signaling known to strongly impact in the pathogenesis of this skin disease.

“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 Yale Medical School, said in a statement. "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

The condition of CHE, a heterogeneous, inflammatory skin condition whose pathophysiology leads to dysfunction in the skin inflammation, issues with the skin barrier, and shifts on skin microbiome, can heavily impact patients’ social, psychological, and occupational wellbeing.

CHE is believed to affect around 9% of the US population, with symptoms of the disease including pruritus, pain, lichenification, hyperkeratosis, scaling, fissures on the hands and the wrists, and others.

This acceptance of the cream’s regulatory submission is known to be based on phase 3 findings in the DELTA 1 and DELTA 2 clinical studies. These trials assessed use of twice-per-day delgocitinib 2%, evaluating the treatment’s safety and efficacy versus a vehicle cream.²

DELTA 1 and 2 were shown to have met their primary endpoints and all of their secondary endpoints. It was noted that 20% of those treated achieved success in Investigator’s Global Assessment (IGA) for chronic hand eczema treatment (IGA-CHE TS) versus 10% in the vehicle arm in DELTA 1, and 29% achieved IGA-CHE TS versus 7%, respectively, in DELTA 2. Results were statistically significant (P ≤ .0055).²

Participants who completed the 16 weeks of DELTA 1 or DELTA 2 were extended an offer by the investigators to take part in the open-label, 36-week DELTA 3 extension trial.¹

“With today’s announcement, we reinforce our commitment to addressing the high unmet need of US 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 statement. “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

References

1. ^{FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema. Leo Pharma. September 23, 2024. https://www.businesswire.com/news/home/20240923600460/en/FDA-Accepts-LEO-Pharma%E2%80%99s-Filing-of-Delgocitinib-Cream-New-Drug-Application-for-the-Treatment-of-Chronic-Hand-Eczema. Date accessed: September 23, 2024.}
2. ^{Smith T. Delgocitinib Cream Effective Over 16 Weeks for Chronic Hand Eczema. HCPLive. July 28, 2024. https://www.hcplive.com/view/delgocitinib-cream-effective-over-16-weeks-chronic-hand-eczema. Date accessed: September 23, 2024.}