LEO Pharma Inc. (Canada) Finalizes Letter of Intent with pCPA for Anzupgo® (delgocitinib cream) for Chronic Hand Eczema

BALLERUP, Denmark--(BUSINESS WIRE)--ANZUPGO (delgocitinib cream) has taken a major step towards public reimbursement in Canada following the successful conclusion of negotiations between pan-Canadian Pharmaceutical Alliance (pCPA) and LEO Pharma Canada. This marks important progress toward access for adults with moderate to severe chronic hand eczema (CHE) whose disease is inadequately controlled with, or for whom treatment with topical corticosteroids is not advisable.1 The completion of pCPA negotiations, resulting in a signed Letter of Intent (LOI), is an important milestone toward public reimbursement.



For too long, patients and healthcare professionals have had limited treatment options for chronic hand eczema. The conclusion of pCPA negotiations is an important step toward changing that. We're proud that Canadian patients and investigators played a significant role in Anzupgo's development and look forward to working with public drug plans and with INESSS in Quebec to support timely and equitable access for eligible patients across Canada.” – Jill Archibald, General Manager, LEO Pharma Canada

Anzupgo® is the first topical treatment specifically indicated for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or are not advisable.2 It is supported by the Phase III DELTA clinical program including the pivotal DELTA 1 and DELTA 2 studies.3 The DELTA FORCE study demonstrated superiority in efficacy and a more favourable safety profile compared to standard of care (oral alitretinoin) over 24 weeks.4 Approximately 17% of patients enrolled across the adult DELTA clinical program were Canadian, a testament to the strong Canadian research community in dermatology.

"Chronic hand eczema that remains refractory to topical corticosteroids can significantly impair patients' daily functioning and quality of life. For well over a decade, there has been a clear need for more effective treatments for patients. The DELTA clinical trial program demonstrated robust efficacy outcomes and showed superiority compared to the current standard of care, alitretinoin. With pCPA negotiations now finalized, we are one step closer to broad patient access to Anzupgo®" – Dr. David Adam, Medical Director, Baywood Dermatology, President of the Dermatology Association of Ontario, and Investigator in the DELTA clinical program

CHE can have a significant impact on quality of life, daily functioning, and employment.5 This burden is felt most acutely by healthcare professionals who spend their days washing their hands, wearing gloves, and working with irritants.6

“Chronic hand eczema can be itchy, painful, and can negatively impact daily life for patients. The condition can disrupt work, sleep, self-care, and daily tasks. This progress toward reimbursement offers new hope to this patient community." – Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada

A pan-Canadian survey of nurses conducted in December 2024 found that 75% of nurses with CHE reported the condition significantly impacted their ability to work.7 In December 2025, Canadian nursing associations formally wrote to the Chief Nursing Officer of Canada urging that CHE be recognized as a significant occupational health issue requiring national action.8

“Protecting patients should not come at the expense of nurses’ health,” said Amy Wright, President of the Canadian Association of Neonatal Nurses. “CHE is not a minor skin issue; it affects nurses’ ability to work, their well-being, and ultimately the sustainability of our healthcare system.”

The successful completion of pCPA negotiations follows a positive reimbursement recommendation from Canada’s Drug Agency (CDA-AMC).9 LEO Pharma looks forward to continued collaboration with reimbursement stakeholders across Canada as listing decisions are considered, and remains committed to ongoing dialogue with the Institut national d'excellence en santé et services sociaux (INESSS) and hopes to see patients in Quebec benefit from access to this innovative treatment in due course.

About Chronic Hand Eczema

CHE is an inflammatory skin condition causing persistent itch, pain, and skin breakdown on the hands and wrists that significantly impairs daily functioning, work capacity and mental health. It affects approximately 6% of Canadians with substantially higher rates among nurses and others in wet-work occupations.10

About Anzupgo® (delgocitinib cream)

Anzupgo® is the first topical treatment specifically indicated for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or are not advisable.2 A topical pan-Janus kinase (JAK) inhibitor, Anzupgo® inhibits JAK-STAT signalling, which plays a key role in the pathogenesis of CHE.2,3

About LEO Pharma Inc.

LEO Pharma is a global leader in medical dermatology dedicated to advancing the standard of care for people with skin conditions, their families and society. LEO Pharma has maintained a presence in Canada for over 40 years. For more information, visit https://www.leo-pharma.ca/en-ca

MAT-98072

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

References:

  1. Anzupgo® pCPA Negotiation Timelines. https://pcpa-app.ca/browse-negotiations/76392
  2. Anzupgo® (delgocitinib cream) Health Canada Product Monograph. [Product Monograph Template - Standard]
  3. 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 - The Lancet
  4. 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
  5. Full article: Health-related quality of life in individuals with Chronic hand eczema – Findings from the multinational CHECK study
  6. Prevalence and incidence of hand eczema in healthcare workers: A systematic review and meta‐analysis - Yüksel - 2024 - Contact Dermatitis - Wiley Online Library
  7. caccn.ca/wp-content/uploads/2025/05/2025-04-Final-SDEL2406_CHE-Nurses-Survey-Whitepaper_612x792_EN_S04.pdf
  8. CHE-Impact-on-Nurses-Unified-Letter-Dec2025.pdf
  9. CDA-AMC recommendation: Delgocitinib (Anzupgo)
  10. 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 | British Journal of Dermatology | Oxford Academic

 


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