Delgocitinib Approved by FDA for Chronic Hand Eczema

The FDA has approved delgocitinib cream as a topical treatment for moderate-to-severe chronic hand eczema (CHE) in adults, the manufacturer announced on July 23.

With this approval, delgocitinib (Anzupgo), a JAK inhibitor, becomes the first treatment specifically indicated for adults with moderate-to-severe CHE in the United States, according to the company, Leo Pharma. The New Drug Application was filed in September 2024 for 20 mg/g (2%) delgocitinib cream; the approved indication is for topical treatment of moderate-to-severe CHE in adults “who have had an inadequate response to, or for whom topical corticosteroids are not advisable.” 

Delgocitinib is a topical pan-JAK inhibitor, which inhibits the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2, according to the manufacturer.

In the phase 3 data DELTA 1 and DELTA 2 clinical trials of nearly 1000 adults with moderate-to-severe CHE, published in The Lancet in August, 2024, adults with moderate-to-severe CHE were randomized to twice-daily application of delgocitinib cream or a cream vehicle for 16 weeks. A total of 486 adults with CHE were enrolled in DELTA 1 and 473 in DELTA 2.

The primary endpoint was treatment success based on the Investigator’s Global Assessment of Chronic Hand Eczema scores of 0 or 1 (clear or almost clear). 

After 16 weeks of twice-daily application, significantly more patients in the treatment groups in DELTA 1 and 2 met the primary endpoint compared with those on the vehicle (20% vs 10%; P = .0055; and 29% vs 7%; P < .0001, respectively). The proportion of patients reporting adverse events with delgocitinib and the vehicle cream was similar in both studies: 45% vs 51%, respectively, in DELTA 1; and 46% vs 45%, respectively, in DELTA 2.

An open-label extension study, DELTA 3, showed similar results. Approximately 30% of patients in the delgocitinib group and those rolled over from a placebo group met criteria for clear or almost clear at 36 weeks.

The most common adverse events (occurring in at least 2% of patients) were COVID-19 and nasopharyngitis; rates were similar in the treatment groups in both studies. 

In 2024, delgocitinib cream was approved for treating CHE in Europe, launching in countries such as Germany and Switzerland, as well as the United Kingdom and the United Arab Emirates, according to Leo Pharma. 

The company’s statement says that it is working to make delgocitinib available to patients in the United States “as soon as possible.” 

The DELTA studies were funded by Leo Pharma.