LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA

• LEO Pharma has submitted a label expansion application to EMA to expand Anzupgo® (delgocitinib) cream to adolescent patients (12–17 years) with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate – the application has been accepted for review.
• The application is supported by results from DELTA TEEN, a phase 3 trial investigating efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema (CHE).¹
• The label expansion submission for adolescent patients demonstrates LEO Pharma's commitment to investigating use within relevant sub-populations where treatments can help make a fundamental difference for patients with skin diseases.

BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today announced submission of a label expansion application to the European Medicines Agency (EMA) to expand the use of Anzupgo^® (delgocitinib) cream to adolescents aged 12 to 17 years, living with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate in the European Union. The label expansion application has been accepted for review by EMA.

“With the submission of our label expansion application for Anzupgo^®, LEO Pharma is reinforcing our commitment aiming at improving the lives of patients with skin diseases,” said Sophie Lamle, Executive Vice President, Development. “Adolescents living with this debilitating disease, in the EU, currently have no treatment options specifically approved for moderate to severe CHE, and we are proud to take this important step toward addressing that unmet need. Backed by our global expertise and dedication to innovation, we are excited about the potential to bring a treatment that can help make a meaningful difference in the everyday lives of adolescent patients.”

Research on adolescents with CHE shows that the disease can impact far beyond the skin. CHE can have considerable negative impact on quality of life, affecting psychosocial well-being, school performance and participation in leisure activities.²

The label expansion application is supported by results 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 adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate .¹ The detailed results were presented as a late breaking presentation at European Academy of Dermatology and Venereology 2025 in Paris, France.

Anzupgo^® is currently approved in adult patients with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate in the European Union³, as well as several additional markets, including the US, Switzerland and the UK.

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.^4,5 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^6,7 In a substantial number of patients, HE can develop into a chronic disease.⁶ 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.⁸

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^9,10 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.¹¹ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹²

About Anzupgo^® (delgocitinib) Cream

Anzupgo^® cream is a topical 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.¹³

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. Anzupgo^® cream is also under investigation in other markets.

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.¹⁴

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

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

About the DELTA TEEN Trial

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

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

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. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin.

For more information, visit www.leo-pharma.com.

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. 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.
3. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA; 2024 [updated 2025 Jan 22; cited 2025 Dec 9]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
4. 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.
5. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
6. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
7. 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
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.

MAT-88642 December 2025