FDA Approves First Targeted Treatment for Chronic Hand Eczema

Leo Pharma has secured a groundbreaking FDA approval for Anzupgo (delgocitinib), marking a significant milestone in the treatment of chronic hand eczema (CHE). This Danish dermatology specialist's achievement introduces the first therapeutic in the United States specifically indicated for CHE, a condition affecting approximately 10% of adults worldwide.

Anzupgo: A New Era in CHE Treatment

Anzupgo, a topical JAK inhibitor cream, has been approved for adults with moderate to severe CHE who have found topical corticosteroids inadequate or unsuitable. This approval follows its earlier authorization in Europe, where it became the first topical treatment for CHE in September 2024.

The FDA's decision addresses a long-standing gap in CHE treatment options. A recent Ipsos study commissioned by Leo Pharma revealed that over half of surveyed dermatologists expressed frustration with the lack of progress in this indication. Dr. Christopher Bunick, associate professor of dermatology at Yale School of Medicine, hailed the approval as "a victory for CHE patients," noting that it "immediately elevates the standard of care for patients who have long awaited a better quality of life."

Mechanism of Action and Clinical Efficacy

Anzupgo's effectiveness lies in its ability to inhibit the JAK-STAT pathway, blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2. This mechanism suppresses inflammatory responses that trigger CHE onset and subsequent flares. As the first topical pan-JAK inhibitor in the U.S. market, Anzupgo distinguishes itself from selective JAK inhibitors by targeting multiple JAK enzymes simultaneously.

The FDA approval was supported by three successful phase 3 trials. In two identical studies, Anzupgo demonstrated superiority over placebo cream. A separate head-to-head trial showed Anzupgo outperforming GSK's oral treatment Toctino (alitretinoin), which is approved in Europe but not in the U.S. After 12 weeks, Anzupgo patients experienced a significantly greater reduction in hand eczema severity index scores compared to Toctino patients (67.6-point vs. 51.5-point reduction on a 360-point scale).

Market Impact and Future Prospects

Leo Pharma's CEO, Christophe Bourdon, emphasized the company's commitment to addressing difficult-to-treat skin conditions, stating that 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."

In preparation for the launch, Leo Pharma has expanded its U.S. operations, including a 50% increase in its sales force. While pricing details for Anzupgo in the U.S. market have not been disclosed, the approval is expected to significantly impact Leo Pharma's presence in the country.

The CHE treatment landscape may see further developments in the near future. Other companies, including Regeneron and Sanofi with their blockbuster drug Dupixent, are pursuing approvals in this indication. Clinical-stage biotechs Asana BioSciences and Afecta Pharmaceuticals also have promising compounds in development for CHE, according to GlobalData.

As the first FDA-approved targeted treatment for CHE, Anzupgo represents a significant advancement in dermatological care, offering new hope for millions of patients struggling with this chronic condition.