LEO Pharma Announces Health Canada Approval of Anzupgo® for Treatment of Moderate to Severe Chronic Hand Eczema

Anzupgo^® (delgocitinib cream 20 mg/g) is the first topical treatment to be specifically indicated for adult patients living with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or are not advisable.¹

• Approval was based on results from the DELTA 1 and 2 trials, which evaluated the safety and efficacy of Anzupgo^® compared to cream vehicle.²
• CHE is one of the most common skin disorders of the hands with a global prevalence rate of approximately 4.7 per cent, and an estimated 6 per cent among Canadians.²,³

TORONTO, Aug. 26, 2025 /CNW/ - LEO Pharma Inc., Canada is pleased to announce that Health Canada has approved Anzupgo^® (delgocitinib cream 20 mg/g) for the treatment of adult (aged ≥18 years) patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or are not advisable. Anzupgo^® is the first topical treatment specifically indicated for CHE, one of the most common skin disorders of the hands.³ CHE affects approximately 4.7 per cent of the population globally, and an estimated 6 per cent of Canadians.²,⁴

The Health Canada approval is based on the results from the DELTA 1 and 2 clinical trials, which included 960 adult patients with moderate to severe CHE (20 per cent of which were Canadian).^2,3 Both trials met their primary and key secondary endpoints and showed that Anzupgo cream provided overall superior efficacy versus cream vehicle and was well tolerated over 16 weeks.²

"Living with chronic hand eczema can significantly impact a patient's quality of life, affecting their ability to perform daily activities and their overall well-being," said Dr. Melinda Gooderham, Dermatologist, Medical Director at the SKiN Centre for Dermatology and Principal Investigator for the SKiN Research Centre. "The approval of Anzupgo^® provides a new treatment option that targets underlying inflammation and helps manage the symptoms of this debilitating condition."

Anzupgo^® is the first topical pan-Janus kinase (JAK) inhibitor to be approved in Canada specifically for moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.^1,5

"Hand eczema can have a profound effect on everyday living and can impact an individual's everyday tasks, family life, ability to work, and mental health," added Executive Director of the Eczema Society of Canada, Amanda Cresswell-Melville. "More treatment options means more hope for those impacted by this challenging condition."

Jill Archibald, President and CEO, LEO Pharma Inc., Canada noted, "As a leader in medical dermatology, the approval of Anzupgo^® represents our company's ongoing commitment to developing new medicines to treat skin diseases in Canada. We are pleased to bring the first and only topical specifically indicated for adults living with moderate-to-severe chronic hand eczema to Canada, offering patients a novel choice in the management of their condition."

Anzupgo^® is currently expected to be available to patients and healthcare professionals in Canada in 2025.

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.^6,7 HE is the most common skin disorder of the hands¹¹ with a prevalence rate of approximately 4.7%.⁸ In a substantial number of patients, HE can develop into a chronic condition.⁹ CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.¹⁰

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹¹ with approximately 70% of individuals who live with severe CHE experiencing problems in performing everyday activities, and suffering disruption in their daily life due to the condition.¹² Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹³ In fact a survey of Canadian nurses found that just under 80% shared their CHE symptoms get worse by unavoidable job-related triggers.¹⁸

About Anzupgo^® (Delgocitinib Cream)

Anzupgo^® (delgocitinib) cream is currently approved in the United States, 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 inappropriate.

Anzupgo^® cream is a topical pan-Janus kinase (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.¹² The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹³

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 Anzupgo^® cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

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 application of Anzupgo^® (delgocitinib cream 20 mg/g) (2%) compared with cream vehicle in the treatment of adults with moderate to severe CHE.^2,14,15

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).^2,16,17

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 to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials. ^2,16,17

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 continue in 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^®.^16,17

Of the 801 participants in the DELTA 3 trial, approximately 20 per cent were Canadian.

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  

MAT-77975 November 2024

Anzupgo^® is a registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc. Canada

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¹ Anzupgo^® (delgocitinib cream) Canada Product Monograph. November 2024

² Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4.

³ Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3

⁴ Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.

⁵ 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. July 18. https://doi.org/10.1016/S0140-6736(24)01027-4

⁶ 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. 

⁷ Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. 

⁸ Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3. 

⁹ 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. 

¹⁰ Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.  

¹¹ 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.

¹² 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.

¹³ Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. 

¹⁴ ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. https://clinicaltrials.gov/study/NCT04871711.  

¹⁵ ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101. 

¹⁶ ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841 https://clinicaltrials.gov/ct2/show/NCT04949841. 

¹⁷ Gooderham M, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA. 

¹⁸ https://caccn.ca/wp-content/uploads/2025/05/2025-04-Final-SDEL2406_CHE-Nurses-Survey-Whitepaper_612x792_EN_S04.pdf

SOURCE LEO Pharma

Jes Broe Frederiksen, LEO Pharma Inc., Global Communications Manager, Corporate Affairs, Tel: [phone], Email: [email protected]