(delgocitinib) Cream Is Now the First and Only FDA-Approved Treatment for Moderate-to-Severe Chronic Hand Eczema (CHE) in Adults

Business Wire

4 days ago

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma Inc. announced today that the Food and Drug Administration (FDA) has approved ANZUPGO ® (delgocitinib) cream for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 5
CHE is an inflammatory skin disease with key symptoms of itch and pain, where skin on the hands and wrists can become red, irritated, thickened, blistered, swollen, or cracked. 7 The disease can have a high psychological, social, and occupational burden. 1,7,8
'Chronic hand eczema can be a very difficult disease for adults to manage with no approved treatment options until now,' said Robert Spurr, Executive Vice President, North America, LEO Pharma. 'As the first and only FDA-approved treatment for CHE, 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 an innovative steroid-free, topical pan-Janus kinase (JAK) inhibitor for adults with CHE. 5 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 CHE. 2,5,9
The FDA approval of ANZUPGO is based on two pivotal 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 CHE. 5,6
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 2-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). 5,6
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 CHE patients, 5 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). 5,6
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. 5
'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 Dr. Linda Stein Gold, MD, Henry Ford Hospital."I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms.'
'We're thrilled that the FDA recognizes the impact that moderate-to-severe chronic hand eczema has on patients,' said Kristin Belleson, CEO and President with the National Eczema Association. '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.'
The FDA approval of ANZUPGO marks a significant milestone in LEO Pharma's strategy to expand its presence in the United States market and deliver purposeful innovation in skin health. With a focus on unmet needs, the company continues to advance its ambition to be a global leader in medical dermatology.
'ANZUPGO is a powerful example of how we transform a real need in the market into medicines that are designed to be 'easy to use' and effective for people living with serious skin diseases,' said Christophe Bourdon, CEO, LEO Pharma. 'After successfully launching ANZUPGO in several countries, we're proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States. The approval of ANZUPGO reinforces our commitment to investing in difficult-to-treat skin diseases to deliver new treatments to patients where the need is greatest. We're truly grateful to the patients and physicians who participated in our studies and helped make this approval possible.'
LEO Pharma is working to make ANZUPGO available to patients in the U.S. as soon as possible and is committed to supporting broad, affordable access to all its treatments.
The FDA approval is the latest regulatory milestone for ANZUPGO, following the European Commission (EC) approval in 2024 and numerous launches internationally, including Germany, Switzerland, the United Kingdom and the United Arab Emirates.
About the DELTA 1, 2 and 3 Trials
The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of ANZUPGO ® (delgocitinib) cream 20 mg/g (2%) compared with cream vehicle in the treatment of adults with moderate-to-severe CHE. 6
The primary endpoint of the trials was the Investigator's Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores are 2 (mild), 3 (moderate), and 4 (severe). 6
Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI). The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials. 6
Subjects who completed 16 weeks of treatment with ANZUPGO cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 open-label, multi-site extension trial. The purpose of this extension trial was to evaluate the long-term safety of ANZUPGO. 4
About ANZUPGO ® (delgocitinib) Cream
ANZUPGO ® (delgocitinib) cream is currently FDA-approved in the U.S. as the first and only topical pan-JAK treatment for chronic hand eczema (CHE). ANZUPGO cream is also approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates under the brand name ANZUPGO for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. 5
ANZUPGO cream is a topical pan-JAK inhibitor for the treatment of moderate-to-severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 5
In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.
About Chronic Hand Eczema
Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 7 HE is one of the most common skin disorders of the hands and in a substantial number of patients, it can develop into a chronic condition. 10 CHE affects approximately one in ten adults worldwide. 2,3 It is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 7 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 2
CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 8,11 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities. 12 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 13
INDICATION AND IMPORTANT SAFETY INFORMATION FOR ANZUPGO ® (DELGOCITINIB) CREAM
What is ANZUPGO?
ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids.
The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.
IMPORTANT SAFETY INFORMATION
ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth, or vagina.
What is the most important information I should know about ANZUPGO?
ANZUPGO may cause serious side effects, including:
Serious Infections: ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections.
ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO.
Before starting ANZUPGO, tell your healthcare provider if you:
are being treated for an infection or have an infection that does not go away or that keeps coming back
have TB or have been in close contact with someone with TB
have had shingles (herpes zoster)
have had hepatitis B or C
think you have an infection or have symptoms of an infection such as fever, sweating, or chills; muscle aches; cough or shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinating more often than usual; and/or feeling very tired
After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection. ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled.
Non-melanoma skin cancer. ANZUPGO may increase your risk of certain non-melanoma skin cancers. Your healthcare provider will regularly check your skin during your treatment with ANZUPGO.
Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun, and use a broad-spectrum sunscreen
Tell your healthcare provider if you have ever had any type of cancer
Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking oral or other topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least one heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Oral or other topical JAK inhibitors have also caused increased cholesterol.
Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you:
have an infection
have recently received or are scheduled to receive a vaccine. People who use ANZUPGO should not receive live vaccines right before starting, during treatment, or right after treatment with ANZUPGO
are pregnant or plan to become pregnant. It is not known if ANZUPGO will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if ANZUPGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ANZUPGO. If you use ANZUPGO while breastfeeding, avoid touching the nipple and surrounding area right away after applying ANZUPGO to your hands and wrists
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the most common side effects of ANZUPGO?
application site reactions, including pain, tingling, itching, and redness; bacterial skin infections, including finger cellulitis and nail infections; and low white blood cells
These are not all of the possible side effects of ANZUPGO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide.
About LEO Pharma
LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.
References
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ANZUPGO ® (delgocitinib) cream. Prescribing Information. FDA. July 2025.
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Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.
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