Regulatory approval is based on clinical trials showing improvements in symptom severity and treatment success at 16 weeks.
LEO Pharma Inc announced that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream for the topical treatment of moderate-to-severe chronic hand eczema in adults who have had an inadequate response to, or are not advised to use, topical corticosteroids.
According to a release from the company, the treatment is the first and only FDA-approved treatment for chronic hand eczema in adults.
“Chronic hand eczema can be a very difficult disease for adults to manage with no approved treatment options until now,” says Robert Spurr, executive vice president, North America, LEO Pharma, in a release. “…Anzupgo 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.”
Anzupgo is a steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with chronic hand eczema. Anzupgo 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 chronic hand eczema.
Clinical Trial Results
The FDA approval of Anzupgo is based on two randomized, double-blind, vehicle-controlled studies of identical design, DELTA 1 and DELTA 2, that evaluated the safety and efficacy of ANZUPGO in a total of 960 patients, 18 years of age and older, with moderate-to-severe chronic hand eczema.
The primary efficacy endpoint of both trials was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline. In DELTA 1, 20% of patients treated with Anzupgo achieved this outcome versus 10% with cream vehicle (p=0.006). In DELTA 2, 29% of Anzupgo-treated patients achieved IGA-CHE TS compared to 7% for cream vehicle (p<0.0001).
Both trials also met all their key secondary endpoints. Using the Hand Eczema Symptom Diary (HESD) to measure the severity of itch (n=949) and pain (n=875) in chronic hand eczema patients, at week 16, 49% of patients treated with Anzupgo in DELTA 1 and 49% in DELTA 2 achieved a ≥4-point reduction in HESD pain score, compared to 28% and 23% for pain in the cream vehicle groups (p<0.0001).
Further, at week 16, 47% of patients treated with Anzupgo in DELTA 1 and 47% in DELTA 2 achieved a ≥4-point reduction in HESD itch score, compared to 23% and 20% for itch in the cream vehicle groups (p<0.0001).
Clinical studies found that Anzupgo offers a favorable safety profile comparable to cream vehicle. Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.
Treament for Chronic Hand Eczema Patients
“In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of [chronic hand eczema] places on patients and the challenges they face living with it,” says Linda Stein Gold, MD, Henry Ford Hospital, in a release. “I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms.”
LEO Pharma is working to make Anzupgo available to patients in the US as soon as possible, according to a release from the company.
The FDA approval follows the European Commission approval in 2024 and numerous launches internationally, including Germany, Switzerland, the United Kingdom, and the United Arab Emirates.
“We’re thrilled that the FDA recognizes the impact that moderate-to-severe chronic hand eczema has on patients,” says Kristin Belleson, CEO and president of the National Eczema Association, in a release. “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 Anzupgo provides hope and promise for the eczema community and those seeking lasting relief from disruptive symptoms.”
Photo caption: Anzupgo (delgocitinib)
Photo credit: LEO Pharma
