LEO Pharma Receives Positive CHMP Opinion Recommending Anzupgo® (delgocitinib) Cream for Adolescents With Moderate to Severe Chronic Hand Eczema in the EU

• The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate.
• If approved by the European Commission, Anzupgo® would become the first therapy in the EU specifically approved for adolescents with moderate to severe chronic hand eczema, a patient population for whom there are currently no specifically approved treatment options.
• The positive CHMP opinion is supported by results from DELTA TEEN, a phase 3 trial investigating the efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema.¹

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a label expansion for Anzupgo® (delgocitinib) cream to include adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate in the European Union.

“Today’s positive CHMP opinion marks an important step toward making Anzupgo® available to adolescent patients living with moderate to severe chronic hand eczema in the EU,” said Sophie Lamle, Executive Vice President, Development, LEO Pharma. “Chronic hand eczema can have a significant impact on young people’s daily lives, including their psychosocial well-being, school performance and participation in leisure activities, and we are proud to move closer to addressing this unmet need.”

Adolescents living with chronic hand eczema may experience symptoms such as itch, pain, blistering and swelling, which can interfere with daily life.² As a chronic disease with recurring flares affecting the hands, adolescent chronic hand eczema can also place a significant functional and psychosocial burden on patients and their families, affecting daily activities, school, social confidence and caregiver well-being.^3–10 Yet the condition remains underserved, with no treatment options specifically approved for adolescent patients in the EU and topical corticosteroids not always being adequate or appropriate.^11–14 These challenges underscore the need for timely intervention and approved, non-steroidal topical treatment options for adolescents living with chronic hand eczema.

The CHMP opinion is supported by results from DELTA TEEN, a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel-group, multi-site trial evaluating twice-daily applications of Anzupgo® compared with cream vehicle in adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate.¹ The primary endpoint of DELTA TEEN was Investigator’s Global Assessment for chronic hand eczema treatment success at Week 16, defined as an IGA-CHE score of 0 — clear — or 1 — almost clear — with at least a two-step improvement from baseline.¹ The trial met the primary endpoint and key secondary endpoints.¹⁵

Anzupgo® is currently approved in the European Union for adult patients with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate.¹¹ Anzupgo® is also approved in several additional markets, including the United Kingdom, Switzerland, Canada, Australia, South Korea, and the United States for adults with chronic hand eczema.^11,21

About Chronic Hand Eczema

Chronic hand eczema (CHE) is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.^12,13 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^14,16 In a substantial number of patients, hand eczema can develop into a chronic disease.¹⁴ 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.¹⁷

CHE has been shown to cause psychological and functional burdens that impact patient quality of life.^6,18 Approximately 70% of adults who live with severe CHE have reported problems in performing everyday activities and disruption in their daily life due to the condition.¹⁹

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.²⁰

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 in adults for whom topical corticosteroids are inadequate or inappropriate.¹¹ 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 in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ²¹

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi and Co. Ltd. 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. Available at: https://clinicaltrials.gov/study/NCT05355818. Accessed February 2026.
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. Johannisson A, Svensson A. Acta Derm Venereol. 2005;85(1):38–41.
4. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05355818. Accessed February 2026.
5. Molin S, et al. Abstract presented at the European Society of Contact Dermatitis Congress; June 24–27, 2026; Copenhagen, Denmark.
6. Golics CJ, et al. Dermatology. 2009;218:357–366.
7. Halvorsen JA. J Invest Dermatol. 2014;134(7):1847–1854.
8. Lee HJ, et al. Acta Derm Venereol. 2023;103:2242.
9. Moore K, et al. Br J Dermatol. 2006;154(3):514–518.
10. Vicho-de-la-Fuente N, et al. J Adv Nurs. 2025;81:4360–4387.
11. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo.
12. 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;15(6):360.
13. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1–22.
14. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24:1–20.
15. 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.
16. 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.
17. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357–378.
18. 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.
19. 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.
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;17:233.
21. ANZUPGO® (delgocitinib) cream. Prescribing Information. FDA. July 2025.

MAT-99226 September 2026

Christian Bundgaard
Global Corporate Communication
+45 53 74 88 49
chbun@leo-pharma.com

Jes Broe Frederiksen
Global Corporate Communication
+45 53 60 59 48
jebfe@leo-pharma.com