Chronic hand eczema (CHE) is more than just skin deep; it’s a prevalent condition impacting approximately 1 out of every 20 people globally. Individuals affected by CHE often face significant challenges related to skin barrier dysfunction and alterations to their skin microbiome, which can lead to discomfort, emotional stress, and reduced quality of life. Surprisingly, until recently, there were no FDA-approved treatments available for this condition within the United States. But change is on the horizon with delgocitinib, now marketed as Anzupgo, paving the way for hope.
LEO Pharma, the Danish pharmaceutical company behind Anzupgo, recently announced two significant regulatory milestones. The first is the U.S. Food and Drug Administration’s (FDA) acceptance of their New Drug Application (NDA) for delgocitinib cream, which is geared toward adults suffering from moderate to severe CHE who do not respond adequately to topical corticosteroids. The second milestone involves the European Commission (EC) granting marketing authorization for Anzupgo across the European Union and several select countries.
“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...” remarked Christophe Bourdon, CEO of LEO Pharma A/S, reflecting on the immense responsibility and opportunity they see with the introduction of this new treatment.
At its core, delgocitinib cream works as a pan-Janus kinase (JAK) inhibitor, targeting multiple cytokine pathways involved with CHE — this innovative approach sets it apart from existing treatments. According to clinical data, delgocitinib displayed promising results during phase 3 clinical trials known as DELTA 1 and DELTA 2. These trials indicated not only safety but also effective symptom management compared to placebo treatments.
“What makes delgocitinib special is its ability to target multiple cytokine pathways contributing to CHE,” explained Dr. Christopher Bunick, MD, PhD, associate professor at Yale University. Bunick emphasized how this drug's profile could herald substantial improvements for patients long awaiting effective therapies for what is referenced as a condition with high unmet medical need.
CA patient-reported outcomes from the DELTA trials also reinforce the significance of this approval, showcasing improvements not only from the perspective of inflammation but also with regard to daily activities affected by CHE symptoms. During the trials, participants exhibited reduced itch and pain along with heightened quality-of-life metrics.
The DELTA studies showed both primary and secondary endpoints were met, leading participants to join the subsequent 36-week DELTA 3 open-label extension trial, which allows continued evaluation of long-term safety and efficacy.
The impact of CHE extends beyond physical symptoms; it weighs heavily on mental health and social interactions. “CHE can be debilitating and affects the everyday lives of many individuals,” said Kreesten Meldgaard Madsen, LEO Pharma’s chief development officer. “Our treatment option aims to support the management of this debilitating condition.”
With both the FDA and EC making strides to support patients suffering from this debilitating condition, delgocitinib holds the potential to transform the current treatment paradigm, particularly for individuals whose hope for effective therapies has historically been overshadowed by limited options.
The FDA's review of the NDA is expected to conclude by late 2025, marking yet another important milestone as stakeholders prepare for the launch of Anzupgo. The dermatological community looks forward to embracing this innovative treatment, hoping it significantly alters the management of chronic hand eczema.
