Two Major Regulatory Milestones Announced for Delgocitinib for CHE

Image Credit: © Ольга Тернавская - stock.adobe.com

LEO Pharma announced today 2 major regulatory milestones concerning delgocitinib cream for the treatment of Chronic Hand Eczema (CHE). The US Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) for the cream, while the European Commission (EC) has granted marketing authorization for the product, branded as Anzupgo, in the European Union and select European countries.^1-2

Delgocitinib cream, formulated at 20 mg/g (2%), targets adults suffering from moderate to severe CHE who have not adequately responded to topical corticosteroids or for whom these treatments are not advisable. There are currently no FDA-approved treatments for this condition in the US.

“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 press release. “This news is testament to our dedication to making a fundamental difference for those who need us most in medical dermatology. Alongside our ongoing efforts in Europe, we will approach our work to provide delgocitinib cream in the US with the same determination and dedication.” 

According to the press release, the NDA submission is supported by positive outcomes from phase 3 clinical trials, DELTA 1 and DELTA 2, where delgocitinib cream demonstrated safety and efficacy compared to a cream vehicle. Both trials successfully met their primary and secondary endpoints, leading researchers to invite participants to join a 36-week open-label extension trial (DELTA 3) for further evaluation.

"CHE can be a debilitating condition that affects the everyday lives of approximately 1 in 20 people globally. Today's exciting news that the US FDA has accepted the NDA filing of delgocitinib for CHE is a profound advancement for the dermatology community given the regularity of office visits for CHE. With no current FDA approved medicines for CHE, delgocitinib is poised to make a major improvement in the lives of our patients waiting for a modern, innovative therapy for this condition with high unmet need,” wrote Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at Yale University School of Medicine in New Haven, Connecticut, and Dermatology Times’ 2024 Winter Editor in Chief. “What makes delgocitinib special as a ‘pan-JAK inhibitor’ is its ability to target multiple cytokine pathways contributing to CHE, treating multiple etiologies of CHE each with underlying unique pathologic molecular signatures. Patients and providers will be excited to learn that delgocitinib is extremely safe too, with very negligible systemic absorption and an optimized vehicle for skin delivery. While dermatologists await formal approval of delgocitinib in the US, it has been approved today in Europe for use, and new data on its efficacy, safety and tolerability will be presented and eagerly anticipated at this week's EADV meeting."

CHE's underlying pathology includes skin barrier dysfunction and alterations in the skin microbiome, leading to significant psychological, social, and occupational burdens for patients.

“This approval is the culmination of years of focus and effort, driven every day by the goal to support this patient population,” said Kreesten Meldgaard Madsen, chief development officer, LEO Pharma. “The new treatment option aims to support the management of this debilitating condition, given the limited treatment options for CHE currently approved across Europe”. 

With these dual regulatory milestones, delgocitinib is set to make a substantial impact on the management of CHE. The regulatory process for the NDA in the US is expected to conclude in the second half of 2025, during which LEO Pharma will work closely with the FDA.

“Over the last few years, we have significantly strengthened our presence in the US through a determined effort to support dermatologists in making a difference for those living with skin conditions,” said Brian Hilberdink, EVP and president, Region North America, LEO Pharma. “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. 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.”

References

1. FDA accepts LEO Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema. News release. Business Wire. September 23, 2024. Accessed 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
2. European commission approves LEO Pharma’s anzupgo (delgocitinib) cream for adults with moderate to severe chronic hand eczema (CHE). News release. Business Wire. September 23, 2024. Accessed September 23, 2024. https://www.businesswire.com/news/home/20240923751725/en/European-Commission-Approves-LEO-Pharma%E2%80%99s-Anzupgo%C2%AE-delgocitinib-Cream-for-Adults-with-Moderate-to-Severe-Chronic-Hand-Eczema-CHE