LEO Pharma announces FDA Acceptance of supplemental NDA for ANZUPGO® (delgocitinib) cream for the treatment of Chronic Hand Eczema in children aged 12-17

MADISON, New Jersey, April 15, 2026 - LEO Pharma Inc., a global leader in medical dermatology, today announced that the U.S. FDA accepted its supplemental New Drug Application (sNDA) for ANZUPGO®  (delgocitinib) cream for the treatment of pediatric patients aged 12 to 17 years with moderate to severe chronic hand eczema (CHE). ANZUPGO cream is a topical and non-steroidal pan-Janus kinase (JAK) inhibitor currently approved in the U.S. for the treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to topical corticosteroids (TCS), or for whom TCS are not advisable.

“Pediatric patients living with chronic hand eczema currently have no approved treatment options specifically indicated for CHE, representing a significant unmet medical need,” said Bob Spurr, EVP and President, Region North America, LEO Pharma. “As LEO Pharma continues to expand its presence in the U.S., we are committed to investing in the development and advancement of treatments like ANZUPGO, which is the only approved treatment specifically for chronic hand eczema in adults and, if approved for pediatric patients, could help address this important gap in care.”

The potential expansion of the label builds on existing approvals for adult patients in the U.S² and other regions³, and is reinforcing LEO Pharma’s commitment to advancing care for underserved patient populations. The safety and efficacy of ANZUPGO in pediatric patients aged 12-17 have not been fully evaluated by the FDA.

Pediatric patients with CHE can experience symptoms such as itchy, painful, blistered, or swollen skin that may interfere with daily activities⁴. Pediatric CHE remains an underserved disease with a lack of pediatric-specific CHE guidelines⁴, no approved treatment options specifically indicated for pediatric CHE,  and limitations of long-term and repetitive topical corticosteroids (TCS) use. ^5-8 These challenges highlight the need for timely intervention and approved, non-steroidal topical treatments to help address the unmet needs of pediatric patients with CHE.

“We are incredibly excited to have taken this step in hopefully providing a new treatment for pediatric patients currently lacking options specifically indicated for CHE in the US, said Sophie Lamle, Executive Vice President, Development at LEO Pharma. “For pediatric patients living with chronic hand eczema, the disease can affect them at a formative time in their lives and personal development. The FDA’s acceptance to review this filing brings us one step closer to potentially offering a much-needed treatment option for this underserved population.”

The label expansion application is based on data from DELTA TEEN, a phase 3 trial with ANZUPGO (delgocitinib) 20mg/g cream that investigated  the efficacy and safety of twice-daily applications of ANZUPGO compared with cream vehicle in pediatric patients aged 12-17 years with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.¹ The trial met the primary endpoint and key secondary endpoints, and the detailed results were presented as a late breaking presentation at European Academy of Dermatology and Venereology (EADV) 2025 in Paris, France.⁹

Currently, ANZUPGO is approved for adults in the United States, the European Union, the United Kingdom as well as several other markets for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. ANZUPGO is currently also being reviewed by the European Medicines Agency for adolescents aged 12-17 years with moderate to severe CHE.

About the DELTA TEEN Trial

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, cream vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of ANZUPGO compared with cream vehicle in pediatric patients 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.^1,9

The primary endpoint of DELTA TEEN 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.^1,9

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. ¹⁰ CHE is one of the most common skin diseases of the hands and wrists and affects approximately one in ten adults worldwide. ^11–14 In a substantial number of patients, HE can develop into a chronic disease. ¹³ CHE 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. ¹⁵

CHE has been shown to cause psychological and functional burdens that impact patient quality of life, ^16,17 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. ¹⁸ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. ¹⁹

About ANZUPGO^® (delgocitinib) Cream

ANZUPGO cream is a topical and non-steroidal pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.²⁰

ANZUPGO (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.²

ANZUPGO is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate.¹ ANZUPGO cream is also under investigation in other markets.

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

 

US LABEL INDICATION² 

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. 

 References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818
2. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.
3. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA; 2024 [updated 2025 Jan 22; cited 2026 Apr 14]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
4. Haft MA, Park HH, Lee SS, Sprague JM, Eichenfield LF. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173. 
5. Egeberg A, Schlapbach C, Haugaard JH, et al. Adverse events from topical corticosteroid use in chronic hand eczema: Findings from the Danish Skin Cohort. JAAD Int. 2024;3(14):77–83.
6. Sreeraj M, Nair S, Thomas J, et al. Hand eczema: current concepts in pathogenesis and management. Discover Medicine. 2024;1:15.
7. Meding B, Järvholm B, Andersson C, et al. Differences in irritant contact dermatitis between men and women. J Invest Dermatol. 2005;124:893–897.
8. Veenje S, de Jong EMGJ, Schuttelaar MLA, et al. Hand eczema in children: prevalence and risk factors. Allergol Immunopathol (Madr). 2019;47(2):166–171.
9. Molin S, et al. Efficacy and safety of delgocitinib cream in adolescents with moderate to severe chronic hand eczema: results from the DELTA TEEN phase 3 trial. Oral presentation presented at: European Academy of Dermatology and Venereology (EADV) Congress; 2025.
10. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg . 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
11. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
12. Quaade AS, Simonsen AB, Halling A-S, Thyssen JP, Johansen JD. Prevalence, incidence, and severity of hand eczema in the general population – A systematic review and meta-analysis. Contact Dermatitis. 2021;84:361–374.
13. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
14. 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. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
15. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
16. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
17. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984-991.
18. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
19. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.
20. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.

 MAT-93933 April 2026