LEO Pharma Achieves Landmark FDA Approval for ANZUPGO® (Delgocitinib) Cream to Treat Chronic Hand Eczema in U.S. Adults
LEO Pharma, a global leader in medical dermatology with a deep-rooted focus on treating serious skin diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for ANZUPGO® (delgocitinib) cream 20 mg/g. This novel topical therapy is now officially indicated for the treatment of moderate-to-severe chronic hand eczema (CHE) in adult patients who have shown inadequate response to topical corticosteroids or for whom these treatments are deemed inadvisable.
The FDA’s decision makes ANZUPGO the first and only topical treatment specifically approved in the United States for chronic hand eczema, a condition that has long lacked adequate, targeted therapeutic options. Furthermore, ANZUPGO stands out as the first topical pan-Janus kinase (JAK) inhibitor to receive FDA approval—a distinction that signals a new frontier in how inflammatory skin diseases may be treated.
A New Era in Dermatology: A Steroid-Free Innovation
Unlike corticosteroids that have long dominated the treatment landscape for eczema and related inflammatory skin disorders, ANZUPGO is steroid-free and works via a highly targeted mechanism. Delgocitinib, the active ingredient in ANZUPGO, functions as a topical pan-JAK inhibitor, meaning it inhibits the entire Janus kinase family—JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). By suppressing the JAK-STAT signaling pathway, which plays a critical role in inflammation, ANZUPGO addresses the underlying pathophysiology of CHE, rather than simply masking symptoms.
This mechanism allows ANZUPGO to suppress a broad spectrum of pro-inflammatory cytokines, positioning it as a scientifically advanced treatment for patients who have often been left without effective or sustainable options.
Strategic Expansion and Operational Growth
The FDA approval of ANZUPGO is more than just a regulatory achievement—it represents a pivotal moment in LEO Pharma’s ongoing transformation and strategic expansion in the United States, the world’s largest pharmaceutical market. As part of its broader effort to bring ANZUPGO to American patients, LEO Pharma has undertaken a comprehensive scale-up of its U.S. operations. This includes a 50% increase in its sales force, along with significant enhancements in marketing, market access, and medical affairs functions to ensure successful product introduction and physician engagement.
“ANZUPGO is a good example of how we transform a real need in the market into medicines that can help make a difference for people living with serious skin diseases such as CHE,” said Christophe Bourdon, CEO of LEO Pharma. “After successfully launching ANZUPGO in several countries, we’re proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States. The approval of ANZUPGO reinforces our commitment to investing in difficult-to-treat skin conditions to deliver new treatments to patients where the need is greatest. We’re truly grateful to the patients and physicians who participated in our studies and helped make this approval possible.”
The Burden of Chronic Hand Eczema
Chronic hand eczema (CHE) is a highly burdensome, relapsing inflammatory skin disease that affects approximately 10% of adults worldwide, and its impact goes far beyond the skin. CHE presents with symptoms such as persistent itching, pain, cracking, blistering, and swelling of the hands—all of which can severely interfere with a patient’s ability to carry out everyday tasks, perform work duties, or maintain quality of life. In many cases, patients suffer both physically and psychologically, as the visible and often painful nature of the disease affects their confidence, mental well-being, and social interactions.
Despite the prevalence and debilitating nature of the condition, CHE has remained underserved by existing therapies, especially in the U.S., where no FDA-approved treatments were available specifically for the condition—until now.
“With this approval, patients who have long struggled with the lack of specific therapies finally have access to an FDA-approved treatment developed exclusively for their condition,” said Robert Spurr, Executive Vice President and President of LEO Pharma North America. “As the first and only FDA-approved treatment specifically for CHE in the U.S., ANZUPGO further establishes our company’s real commitment to bringing treatments to market that address unmet needs in medical dermatology.”
Global Momentum: A Track Record of Regulatory and Commercial Success
The FDA nod for ANZUPGO in the U.S. follows a series of recent international milestones for the product. In 2024, the European Commission approved ANZUPGO, and subsequent commercial launches took place in Germany, Switzerland, the United Kingdom, and the United Arab Emirates, where physicians have already begun prescribing the therapy to patients living with CHE.
These international rollouts have provided LEO Pharma with valuable insights into real-world implementation, physician adoption, and patient outcomes, insights that are expected to inform the upcoming U.S. commercialization strategy.
With this cumulative global momentum, ANZUPGO is poised to become a cornerstone therapy in LEO Pharma’s portfolio, particularly as the company shifts toward a more focused pipeline in inflammatory skin diseases and rare dermatologic conditions.
LEO Pharma’s Evolving Pipeline and Mission
Founded in 1908 and headquartered in Denmark, LEO Pharma has evolved into a global dermatology powerhouse operating in more than 100 countries. Its current pipeline includes both topical and systemic therapies aimed at addressing some of the most challenging and underserved areas of dermatology, including atopic dermatitis, hidradenitis suppurativa, and now chronic hand eczema.
The approval of ANZUPGO represents a culmination of years of research, clinical development, and strategic investment, and the company views this moment as validation of its science-driven, patient-centric approach.
“Our mission at LEO Pharma is to transform the standards of care in dermatology,” said Bourdon. “This means not just offering new medicines, but offering the right medicines—those that fill genuine gaps in care and improve the lived experiences of patients around the world.”
Looking Ahead: Launch Plans and Patient Access
LEO Pharma is expected to launch ANZUPGO in the U.S. market in the coming months, with a robust commercial rollout backed by physician education initiatives, payer engagement, and patient support programs. The company has already signaled its commitment to ensuring broad patient access, including working with health insurers and pharmacy benefit managers to secure favorable formulary placement.
Additionally, LEO Pharma will continue to invest in post-marketing research and real-world evidence generation, to deepen understanding of the therapy’s impact across diverse patient populations and clinical settings.
The FDA approval of ANZUPGO cream is not merely an incremental advancement—it’s a transformational milestone that reshapes the treatment landscape for a historically neglected patient population. For adults in the U.S. living with moderate-to-severe chronic hand eczema, the arrival of ANZUPGO offers not only clinical hope but also validation of their medical needs, which have long been unmet by the status quo.
As LEO Pharma brings ANZUPGO to U.S. clinics and pharmacies, the company reinforces its vision of changing lives through dermatological innovation, while simultaneously raising the bar for what is possible in the treatment of complex skin diseases.
