FDA Greenlights First-Ever Cream for Chronic Hand Eczema Treatment

The U.S. Food and Drug Administration (FDA) has granted approval for Anzupgo, the first cream specifically designed for the treatment of chronic hand eczema (CHE). This condition is characterized by inflammation, redness, itching, and cracking of the skin on the hands and wrists.

Anzupgo (delgocitinib cream) is intended for adults suffering from moderate to severe cases of CHE who are unable to use topical steroids or have not responded adequately to them. The CEO of LEO Pharma, the company that developed Anzupgo, emphasized the significance of this approval, highlighting its commitment to addressing challenging skin conditions and providing new treatment options for patients with pressing medical needs.

Chronic hand eczema, while less common than atopic dermatitis, affects approximately 10% of the U.S. population, with symptoms lasting longer than three months or recurring at least twice a year, according to the National Eczema Association. The cream functions by inhibiting JAK enzymes, which contribute to the inflammatory processes that lead to eczema flare-ups.

Various factors, including genetics and exposure to irritants and allergens, are known to exacerbate this type of eczema. Individuals in occupations such as cleaning, hairdressing, and healthcare are particularly vulnerable due to their frequent contact with potential irritants.

Research indicates that CHE can significantly diminish a person's quality of life and mental health. A dermatologist from Detroit expressed approval of the FDA's decision, noting the substantial burden that CHE places on patients. The introduction of Anzupgo is expected to offer a much-needed solution for healthcare professionals seeking effective treatments for this distressing condition.

Clinical trials prior to the FDA's approval demonstrated that patients using Anzupgo experienced a greater likelihood of improvement compared to those treated with a placebo. Notably, this cream does not carry the same boxed warnings associated with other topical and oral JAK inhibitors.

The National Eczema Association also welcomed the FDA's decision, underscoring the profound impact that chronic hand eczema can have on individuals' daily lives and relationships. The approval of Anzupgo is seen as a beacon of hope for those enduring the challenges of this debilitating skin condition.

Before its approval in the United States, Anzupgo had already received authorization in several regions, including the European Union, United Kingdom, Switzerland, and the United Arab Emirates.