FDA Approval Makes Delgocitinib Cream First Chronic Hand Eczema Therapy for Adults

The FDA approved delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adult patients, LEO Pharma announced in a release.¹ The decision makes delgocitinib cream the first and only approved treatment option for this population.

“CHE can be a very difficult disease for adults to manage with no approved treatment options until now,” Robert Spurr, executive vice president of North America at LEO Pharma, said in the release.¹ “As the first and only FDA-approved treatment for CHE, [delgocitinib] represents an important advance for many patients and further establishes our company's commitment to bringing innovative treatments to market that address unmet needs in medical dermatology.”

CHE, otherwise known as hand dermatitis, is a common and inflammatory skin disease. It’s the most prominent occupational skin condition and is most common among professions where hands are typically getting wet, such as health care workers, food handlers, and hairdressers.²

Delgocitinib is the first and only option for the treatment of moderate-to-severe CHE among adults. | image credit: Photo Sesaon / stock.adobe.com

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The symptoms of CHE involve painful itching of the hands, which then become red, irritated, thickened, blistered, swollen, or cracked. Outside of the physical burden this disease presents, it’s also known to have significant psychological, social, and occupational effects.¹

According to a study published in the British Journal of Dermatology, the annual prevalence of CHE is 4.7%, impacting women, 30-to-39-year-olds, employed individuals, and urban-dwelling patients the most.³

With the first approval of a CHE therapy, delgocitinib is now available for millions of people experiencing the common skin condition. However, according to the LEO Pharma news release, its use is recommended for adults with inadequate responses to corticosteroids, or those who are not advised to take corticosteroids.¹

“In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of CHE places on patients, and the challenges they face living with it,” said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Hospital, according to the release. “I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms.”

The approval was based on data from randomized, double-blind studies of identical design: the DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) clinical trials. The main goal of these studies was to explore the efficacy and safety of delgocitinib among a cohort of 960 adult patients who had moderate-to-severe CHE.

“[Delgocitinib] is an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE,” wrote authors of the news release.¹ “[It] inhibits the JAK-STAT pathway, specifically blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), and suppresses the various inflammatory responses that play a key role in the onset and subsequent flares of CHE.”

Both DELTA clinical trials met their primary and secondary endpoints by week 16. Those endpoints were a reduction of CHE severity and an overall successful treatment.

For DELTA 1, 10% more patients were successfully treated compared with the control group, while in the same trial, 21% more patients in the delgocitinib group saw significant reductions in symptoms. In the DELTA 2 trial, 22% more patients were successfully treated compared with the control group and the delgocitinib group saw a 26% greater reduction in symptoms.¹

“We’re thrilled that the FDA recognizes the impact that moderate-to-severe [CHE] has on patients,” said Kristin Belleson, CEO and president of the National Eczema Association.¹ “People living with a debilitating skin disease on their hands find it extremely difficult; it can impact their ability to work, touch, and connect with important people in their lives. The approval of [delgocitinib] provides hope and promise for the eczema community and those seeking lasting relief from disruptive symptoms.”

READ MORE: Dermatology Resource Center

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References

1. ANZUPGO® (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News Release. LEO Pharma Inc. July 24, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults

2. Chronic hand eczema. Wolters Kluwer. June 30, 2025. Accessed July 24, 2025. https://www.uptodate.com/contents/chronic-hand-eczema

3. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Br J Dermatol. 2025 May 19;192(6):1047-1054. doi: 10.1093/bjd/ljaf020.