FDA Approves First Targeted Treatment for Chronic Hand Eczema in the US

In a landmark decision, the US Food and Drug Administration (FDA) has approved Leo Pharma's Anzupgo (delgocitinib) as the first therapeutic specifically indicated for chronic hand eczema (CHE) in the United States. This approval marks a significant milestone in dermatological treatment, addressing a condition that affects approximately 10% of adults worldwide.

Breakthrough in CHE Treatment

Anzupgo, a topical JAK inhibitor cream, has been authorized for use in adults with moderate to severe CHE who have found topical corticosteroids inadequate or unsuitable. This approval comes on the heels of Anzupgo's European authorization in September of the previous year, where it became the first topical treatment approved for CHE in that region.

The FDA's decision is based on the results of three successful phase 3 trials, which demonstrated Anzupgo's superiority over placebo and its efficacy in an open-label extension study. Notably, in a head-to-head trial against GSK's oral treatment Toctino (alitretinoin), Anzupgo showed significantly greater improvement in hand eczema severity index scores after 12 weeks of treatment.

Impact on Patient Care and Medical Community

Dermatologists have welcomed this approval, citing frustration with the lack of progress in CHE treatment options. Dr. Christopher Bunick, associate professor of dermatology at Yale School of Medicine and editor-in-chief of Dermatology Times, hailed the approval as "a victory for CHE patients," emphasizing its potential to improve quality of life for those affected by the condition.

CHE is characterized by itchy, painful, blistered, or swollen skin that can significantly interfere with daily activities. It is considered chronic when it persists for three months or recurs frequently. The approval of Anzupgo provides a new treatment paradigm for this often-overlooked condition, offering hope to patients who have long struggled with limited therapeutic options.

Pharmaceutical Industry Implications

For Leo Pharma, this approval represents a significant step in expanding its presence in the US market. The company has reportedly increased its sales force by 50% in preparation for the launch of Anzupgo. CEO Christophe Bourdon emphasized the company's commitment to investing in difficult-to-treat skin conditions and delivering new treatments where the need is greatest.

As the first topical pan-JAK inhibitor to reach the US market, Anzupgo differentiates itself from other JAK inhibitors by blocking multiple JAK enzymes. This mechanism of action suppresses inflammatory responses that trigger CHE onset and subsequent flares, potentially offering a more comprehensive approach to treatment.

The CHE treatment landscape is likely to evolve further, with other companies such as Regeneron, Sanofi, Asana BioSciences, and Afecta Pharmaceuticals pursuing approvals for their own CHE treatments. This increased focus on CHE therapies suggests a growing recognition of the condition's impact and the need for targeted treatments in dermatology.