Summary Basis of Decision for Anzupgo

Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The SBD for Anzupgo is located below.

The SBDs written for eligible drugs (as outlined in Frequently Asked Questions: Summary Basis of Decision [SBD] Project: Phase II) approved after September 1, 2012 will be updated to include post-authorization information. This information will be compiled in a Post-Authorization Activity Table (PAAT). The PAAT will include brief summaries of activities such as submissions for new uses of the product, and whether Health Canada's decisions were negative or positive. The PAATs will be updated regularly with post-authorization activity throughout the product life cycle.

The following table describes post-authorization activity for Anzupgo, a product which contains the medicinal ingredient delgocitnib. For more information on the type of information found in PAATs, please refer to the Frequently Asked Questions: SBD Project: Phase II and to the List of abbreviations found in Post-Authorization Activity Tables (PAATs).

For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.

Updated: 2025-12-24

Drug Identification Number (DIN):

DIN 02560704 - 20 mg/g delgocitinib, cream, topical administration

Post-Authorization Activity Table (PAAT)

Date SBD issued: 2025-12-24

The following information relates to the New Drug Submission for Anzupgo.

Delgocitinib

Drug Identification Number (DIN): 02560704 - 20 mg/g delgocitinib, cream, topical administration

LEO Pharma Inc.

New Drug Submission Control Number: 282015

Submission Type: New Drug Submission (New Active Substance)

Therapeutic Area (Anatomical Therapeutic Chemical [ATC] Classification, second level): D11 Other dermatological preparations

Date Filed: 2023-12-13

Authorization Date: 2025-08-25

On August 25, 2025, Health Canada issued a Notice of Compliance to LEO Pharma Inc. for the drug product Anzupgo.

The market authorization of Anzupgo was based on quality (chemistry and manufacturing), non‑clinical (pharmacology and toxicology), and clinical (pharmacology, safety, and efficacy) information submitted. Based on Health Canada’s review, the benefit-harm-uncertainty profile of Anzupgo is favourable for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or are not advisable.

Anzupgo, a pan Janus kinase inhibitor, was authorized for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or are not advisable.

Anzupgo is not authorized for use in pediatric patients (under 18 years of age), as no clinical safety or efficacy data are available for this population.

The reported clinical experience in geriatric patients (65 years of age and older) suggests there are no clinically relevant differences in safety and efficacy between geriatric patients and adult patients less than 65 years of age.

Anzupgo (20 mg/g delgocitinib) is presented as a cream for topical application. In addition to the medicinal ingredient delgocitinib, the cream also contains the following non-medicinal ingredients: benzyl alcohol, butylhydroxyanisole, cetostearyl alcohol, citric acid monohydrate, disodium edetate, hydrochloric acid, liquid paraffin, macrogol cetostearyl ether, and purified water.

The use of Anzupgo is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

The drug product was approved for use under the conditions stated in its Product Monograph taking into consideration the potential risks associated with its administration. The Product Monograph for Anzupgo is available through the Drug Product Database.

For more information about the rationale for Health Canada's decision, refer to the Clinical, Non-clinical, and Quality (Chemistry and Manufacturing) Basis for Decision sections.

Health Canada considers that the benefit-harm-uncertainty profile of Anzupgo is favourable for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or are not advisable.

Hand eczema is a heterogenous chronic inflammatory skin disorder which affects the hands and wrists. Chronic hand eczema refers to an eczematous process that lasts for more than three months or relapses two or more times within 12 months. Chronic hand eczema shows variable morphology, normally with erythema, edema, vesicles, and oozing in the acute phase, followed by erythema, xerosis, scales, lichenification, hyperkeratosis, and fissures when it becomes chronic.

Chronic hand eczema is present in approximately 10% of the general population, with a 1.5 to 2-times higher occurrence in women compared to men. Chronic hand eczema is reported more commonly in adults than in children and adolescents.

Chronic hand eczema can be mild to severe and can be divided into aetiological subtypes (e.g., irritant contact dermatitis, allergic contact dermatitis, atopic hand eczema, protein contact dermatitis) and clinical subtypes (e.g., hyperkeratotic hand eczema, acute recurrent vesicular hand eczema and pulpitis). Risk factors for hand eczema include environmental triggers, atopic dermatitis in childhood, contact allergy, exposure to wet work, cold/dry weather conditions, and low indoor humidity.

Quality of life can be significantly impacted by chronic hand eczema due to visible skin lesions and stigma, limited hand function, and negative consequences of effects on the ability to work or do daily tasks, and can result in reduced work in some occupational settings.

Management of chronic hand eczema includes prevention strategies to reduce the impact of chronic hand eczema and include adequate protection of the skin from irritants, avoidance of triggers of chronic hand eczema, such as allergens, to lessen worsening and flares. Available treatment options for chronic hand eczema are emollients and topical corticosteroids to treat flares.

Currently there are no approved products for the treatment of moderate chronic hand eczema. Alitretinoin, a systemic retinoid, is authorized for the treatment of severe chronic hand eczema in adults who are refractory to high potency topical corticosteroids. However, alitretinoin has several safety concerns and is contraindicated in pregnancy.

Anzupgo is a cream containing 20 mg/g delgocitinib for topical application. Delgocitinib is a pan Janus kinase (JAK) inhibitor that targets all four members of the JAK family of enzymes, JAK1, JAK2, JAK3 and tyrosine kinase 2. Janus kinases are associated with cytokine receptor pathways that act on cytokines to regulate a broad range of physiological and pathological processes. Upon activation by cytokines, JAK signaling activates signal transducers and activators of transcription (STATs) which in turn, activate the expression of cytokine-responsive genes to induce biological responses in target cells. Inhibition of JAK activity with delgocitinib prevents the activation of STATs and blocks multiple cytokine signaling pathways involved in the pathogenesis of chronic hand eczema.

The market authorization for Anzupgo was evaluated based on two pivotal Phase III studies, Studies DELTA 1 and DELTA 2, as well as a long-term extension study, Study DELTA 3.

Studies DELTA 1 and DELTA 2 shared an identical clinical design, consisting of a randomized, double-blind, vehicle-controlled, parallel-group study conducted across multiple sites over a 16-week period. In both studies, the primary endpoint was the proportion of subjects who achieved treatment success, defined as an Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) score of “0” (clear) or “1” (almost clear), with at least a two-step improvement from baseline to Week 16. The IGA‑CHE is a clinician-reported 5-point scoring scale (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). After completing the 16-week treatment period, subjects were then eligible to enter a long-term safety extension, Study DELTA 3, in which they received Anzupgo 20 mg/g cream as needed, when signs and symptoms recurred, for up to 36 weeks.

To further evaluate treatment efficacy, additional secondary endpoints were assessed, including the Hand Eczema Severity Index (HECSI), the Hand Eczema Symptom Diary (HESD), and the Dermatology Life Quality Index (DLQI), measured at various timepoints. The HECSI rates the severity of six clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and edema) and the extent of the lesions on each of the five hand regions (fingertips, fingers, palm of hands, back of hands, and wrists). The HESD is a daily 6-item subject-reported outcome measure designed to assess the worst severity of signs and symptoms of chronic hand eczema (itch, pain, cracking, redness, dryness, and flaking) using an 11-point numeric rating scale. The DLQI is a 10‑question, self-administered questionnaire that measures the impact of skin disease on an individual's health-related quality of life. The questionnaire covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Scores range from “0” to “30”, with higher scores indicating a greater negative impact on quality of life.

Across studies DELTA 1 and DELTA 2, 960 subjects aged 18 years and older with moderate (IGA-CHE score of 3) to severe (IGA-CHE score of 4) chronic hand eczema were enrolled. Chronic hand eczema was defined as eczema that has persisted for more than three months or reoccurred at least twice within the previous 12 months. Upon enrollment, subjects were randomized 2:1 to receive either Anzupgo 20 mg/g cream (639 subjects) or a vehicle cream (321 subjects). Baseline demographics and disease characteristics were generally comparable between the two studies. At the beginning of the study, affected areas of the hands and wrists of the subjects were identified. During the course of the study, subjects were instructed to apply Anzupgo twice daily to the affected areas for the complete 16 weeks, regardless if they cleared up. If new areas were affected during the study, they were treated as well until the end of the study.

Efficacy findings from both Phase III studies consistently demonstrated that Anzupgo cream 20 mg/g was more effective than the vehicle cream (i.e., placebo) in treating adults with moderate to severe chronic hand eczema for the primary endpoint (i.e., IGA-CHE treatment success at Week 16). For the primary endpoint, the proportion of subjects who achieved IGA-CHE treatment success at Week 16, the difference (95% confidence interval [CI]) between Anzupgo and the vehicle cream was 9.8% (95% CI: 3.6, 16.1) with a p‑value = 0.006 in Study DELTA 1, and 22.2% (95% CI: 15.8, 28.5) with a p-value <0.001 in Study DELTA 2. The proportion of responders in the Anzupgo treatment group was higher in Study DELTA 2 (29.1%) than in Study DELTA 1 (19.7%) with a slightly lower proportion of responders in the vehicle cream group in Study DELTA 2 (6.9%) compared to Study DELTA 1 (9.9%).

The results observed for the key secondary endpoints also supported the primary endpoint. Throughout the 16 week treatment period, the proportion of subjects achieving IGA-CHE treatment success, a 75% or 90% improvement in HECSI, a four-point or greater improvement in HESD, HESD itch, HESD pain, and DLQI was consistently higher for Anzupgo-treated subjects compared to vehicle cream-treated subjects. For the majority of endpoint measures, the proportion of responders was similar at Week 8, as at Week 16. This indicates that subjects who do not see improvements in signs and symptoms of chronic hand eczema between 8 and 16 weeks of treatment may not respond to Anzupgo treatment. Based on analysis by the sponsor, the dosing recommendation in the Anzupgo Product Monograph includes a recommendation that subjects who do not see improvement after 12 weeks of treatment should seek re-evaluation by a healthcare professional.

In the long-term safety extension Study DELTA 3, in which subjects applied Anzupgo twice daily as needed, efficacy data showed that the percentage of subjects with an IGA-CHE score of “0” (clear) or “1” (almost clear) remained consistent to Week 36 among subjects previously treated with Anzupgo (25%), and increased from 9.1% at baseline to 26% at Week 36 for subjects previously treated with the vehicle cream. Similarly, for secondary endpoint measurement scores, the proportion of responders remained consistent throughout the “as-needed” treatment period for subjects previously treated with Anzupgo, and increased for subjects previously treated with the vehicle cream.

The clinical safety of Anzupgo was evaluated in 691 subjects aged 18 years and older with moderate to severe chronic hand eczema. The safety evaluation was primarily based on two similar 16 week Phase III studies, DELTA 1 and DELTA 2, and a Phase IIb dose‑ranging study, 1273. Long‑term safety was evaluated based on the extension study, DELTA 3.

The overall proportion of subjects who experienced adverse events was similar between the Anzupgo and vehicle treatment groups, at 48% and 49%, respectively. Severe and serious adverse events occurred in similar proportions and rates in both the Anzupgo and vehicle treatment groups. The majority of the adverse events were non-serious and mild or moderate in severity. During the 36-week extension study (Study DELTA 3), three deaths were reported; however, none were considered related to the study treatment.

No adverse events were reported in more than 10% of subjects treated with Anzupgo. At Week 1, local tolerability issues were observed in a lower proportion of subjects treated with Anzupgo (4.9%) compared to those treated with the vehicle cream (11.1%), and these issues improved over time during the studies.

Overall, application site reactions were less frequent with Anzupgo (1.0%) than with the vehicle cream (2.5%).

Anzupgo has not been studied in combination with other systemic products for the treatment of chronic hand eczema or other topical products. Therefore, using it alongside other therapies on the same area of skin is not recommended. If a subject does not show a response to Anzupgo treatment by Week 12, it is advised that they be re-evaluated by their healthcare provider, based on the efficacy results.

A Risk Management Plan (RMP) for Anzupgo was submitted by LEO Pharma Inc. to Health Canada. The RMP is designed to describe known and potential safety issues, to present the monitoring scheme, and when needed, to describe measures that will be put in place to minimize risks associated with the product. Upon review, the RMP was considered to be acceptable.

The submitted inner and outer labels, package insert and Patient Medication Information section of the Product Monograph for Anzupgo met the necessary regulatory labelling, plain language, and design element requirements.

The sponsor submitted a brand name assessment that included testing for look‑alike sound‑alike attributes. Upon review, the proposed name Anzupgo was accepted.

Overall, Anzupgo has been shown to have a favourable benefit-risk profile based on non-clinical and clinical studies.

This New Drug Submission complies with the requirements of sections C.08.002 and C.08.005.1 and therefore Health Canada has issued the Notice of Compliance pursuant to section C.08.004 of the Food and Drug Regulations. For more information, refer to the Clinical, Non-clinical, and Quality (Chemistry and Manufacturing) Basis for Decision sections.

A pre-submission meeting for the Anzupgo New Drug Submission (NDS) was held on September 14, 2023. The NDS was subsequently filed to Health Canada on December 13, 2023. On December 9, 2024, a Notice of Non-Compliance (NON) was issued due to quality issues. The sponsor submitted a response to the NON on March 6, 2025 and all concerns were satisfactorily addressed. The data package submitted was critically assessed, and the review completed by the European Medicines Agency (EMA) was consulted as an added reference as per Method 3 described in the Draft Guidance Document: The Use of Foreign Reviews by Health Canada. A Notice of Compliance (NOC) was issued based on the Canadian review.

For additional information about the drug submission process, refer to the Guidance Document: The Management of Drug Submissions and Applications.

Submission Milestones: Anzupgo

Requirements for post-market commitments are outlined in the Food and Drugs Act and Food and Drug Regulations.

Summary Basis of Decision documents (SBDs) for eligible drugs (as outlined in Frequently Asked Questions: Summary Basis of Decision [SBD] Project: Phase II) authorized after September 1, 2012 will include post-authorization information in a table format. The Post-Authorization Activity Table (PAAT) will include brief summaries of activities such as submissions for new uses of the product, and whether Health Canada’s decisions were negative or positive. The PAAT will continue to be updated during the product life cycle.

The PAAT for Anzupgo is found above.

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Up-to-date information on drug products can be found at the following links:

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• See the Notice of Compliance with Conditions (NOC/c)-related documents for the latest fact sheets and notices for products which were issued an NOC under the Guidance Document: Notice of Compliance with Conditions (NOC/c), if applicable. Clicking on a product name links to (as applicable) the Fact Sheet, Qualifying Notice, and Dear Health Care Professional Letter.

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• See the Register of Innovative Drugs for a list of drugs that are eligible for data protection under C.08.004.1 of the Food and Drug Regulations, if applicable.

Refer to the What steps led to the approval of Anzupgo? section for more information about the review process for this submission.