/C O R R E C T I O N -- LEO Pharma/
In the news release, Anzupgo® (delgocitinib cream) Now Available in Canada for Adult Patients Living with Moderate to Severe Chronic Hand Eczema, issued 02-Dec-2025 by LEO Pharma over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end:
Anzupgo® (delgocitinib cream) Now Available in Canada for Adult Patients Living with Moderate to Severe Chronic Hand Eczema- Anzupgo® (delgocitinib cream) is the first topical pan-Janus kinase (JAK) 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.i
- Canada's Drug Agency (CDA-AMC) issued a positive recommendationin favour of the reimbursement of Anzupgo® (delgocitinib cream) for the treatment of moderate to severe chronic hand eczema (CHE) in adult patients for whom topical corticosteroids are inadequate or are not advisable.
- In the DELTA FORCE clinical trials, treatment with Anzupgo® (delgocitinib cream) showed superior efficacy and a more favourable safety profile versus oral alitretinoin over 24 weeks. These results support the benefit of delgocitinib cream in patients with severe chronic hand eczema.ii
TORONTO, Dec. 2, 2025 /CNW/ - LEO Pharma Inc., a global leader in dermatology, is pleased to announce the availability of Anzupgo® (delgocitinib cream) across Canada for adults living with moderate to severe chronic hand eczema (CHE). This treatment option marks a significant advancement in addressing the unmet needs of Canadian patients struggling with the taxing symptoms of CHE, for patients for whom topical corticosteroids are inadequate or are not advisable.iii Anzupgo® received Health Canada approval in August 2025. On December 1, 2025, Canada's Drug Agency (CDA-AM) issued a recommendation in favour of reimbursing Anzupgo®.
"At LEO Pharma, we are committed to advancing dermatological care and improving quality of life for Canadians living with chronic skin conditions," said Jill Archibald, President and CEO, LEO Pharma Inc. "The availability of, and a positive reimbursement recommendation for, Anzupgo in Canada are important steps in offering patients new treatment options that offer real relief, both in symptom management and access and we are proud to be a part of this achievement."
Chronic hand eczema is a condition characterized by redness, scaling, and persistent itching and pain; it is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.iv,v CHE affects approximately 6% of people in Canada.vi
CHE can significantly impact quality of life, with around 70% of those with severe cases experiencing disruptions in daily activities especially at work where hand-use and irritants are involved. Without effective treatment, CHE may lead to emotional distress, work absenteeism, and reduced ability to carry out routine tasks.
"My chronic hand eczema really takes a toll on me both mentally and physically," shared Nuzhatullah Obaidi, a patient living with severe hand eczema. "At work is where I notice it the most, where the pain I feel can interrupt my routine and my whole day. I am excited to know that there are new options available for people living with CHE. Every option we have access to means the possibility of relief."
Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada, adds, "Chronic hand eczema can be debilitating and painful, and can negatively impact daily life. Access to approved therapies is essential for the patient community and provides hope."
About Anzupgo® (Delgocitinib Cream)
Anzupgo® (delgocitinib cream) is currently approved in Canada, 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 not advisable.
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.vii The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.viii
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 FORCE Trial
DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.ix
The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. Participants who doctors considered to be benefiting from the treatment were permitted to continue up to 12 weeks.x
All 14 North American DELTA FORCE clinical trial sites were located in Canada.xi
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
Anzupgo® is a registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc. Canada
References
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i Anzupgo® (delgocitinib cream) Canada Product Monograph. November 2024 |
iii Anzupgo® (delgocitinib cream) Canada Product Monograph. November 2024 |
iv 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. |
v Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. |
vi 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. |
vii 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. |
viii Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. |
ix ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://classic.clinicaltrials.gov/ct2/show/NCT05259722. |
x ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://classic.clinicaltrials.gov/ct2/show/NCT05259722. |
xi Giménez-Arnau, Ana Maria et al. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial The Lancet, April 16, 2025 Available at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00001-7/abstract |
Correction: An earlier version of this release incorrectly mentioned "On October 16, 2025" in the last sentence of the 1st paragraph. This should instead read "On December 1, 2025". In the "About Anzupgo® (Delgocitinib Cream)" boilerplate, "adviseable" was corrected to "advisable".
SOURCE LEO Pharma