LEO Pharma’s Anzupgo® (delgocitinib) Cream Achieves Marketing Approval in Switzerland

• The Swiss Agency for Therapeutic Products, Swissmedic, has approved Anzupgo^®, making it the first topical pan-Janus kinase (JAK) inhibitor specifically indicated for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to topical corticosteroids, or for whom potent to very potent topical corticosteroids are not advisable.¹
• The approval will bring a new treatment option to approximately 4.7% of adults in Switzerland living with CHE, a condition with a high unmet need for which no specifically approved topical treatment was previously available.^2,3
• In addition to the results of the DELTA 1,2 and 3 trials, the marketing approval is supported by the head-to-head DELTA FORCE trial of Anzupgo against oral alitretinoin capsules, the only other existing specifically approved treatment for severe CHE.^4-7

BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo^® (delgocitinib) cream. The indication is for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to topical corticosteroids, or for whom potent to very potent topical corticosteroids are not advisable.¹

Anzupgo is the first topical pan-Janus kinase (JAK) inhibitor to be approved in Switzerland specifically for moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.^1,8

“With the Swissmedic approval of Anzupgo, we mark yet another critical regulatory milestone in our effort to advance the standard of CHE care and to bring this treatment to as many patients as possible,” said Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma. “This approval means Anzupgo is the first pan-JAK inhibitor approved for CHE in Switzerland and this highlights LEO Pharma’s unique strength in innovative topicals. We are incredibly excited to introduce a new topical treatment option to adult Swiss patients living with this debilitating disease as soon as possible."

Head-to-head trial with systemic alternative included in Swiss label

In line with the approval in the European Union, the marketing approval of Anzupgo in Switzerland is based on the results from the phase 3 program, which includes the DELTA 1, 2 and 3 clinical trials that evaluated the safety and efficacy of Anzupgo compared to cream vehicle.^4-6,9

In addition, the Swiss approval is supported by the results from the head-to-head DELTA FORCE phase 3 clinical trial, which evaluated the efficacy and safety of Anzupgo compared with oral alitretinoin capsules.¹⁰ Alongside Anzupgo, alitretinoin is the only other treatment currently approved in Switzerland to specifically treat severe CHE in patients who do not respond to topical corticosteroids.^1,11,12

“Introducing the first pan-JAK inhibitor for adult Swiss patients living with CHE in the coming months is a proud moment for us. The approval of Anzupgo was supported by compelling scientific evidence, including a head-to-head comparison with the current standard of care,” said Florian Muschaweck, General Manager, LEO Pharma Switzerland and Austria. "CHE can affect far more than just your skin – including your mental health, your social life and your opportunities to take care of your work or your family. We are excited to be able to offer a new treatment option to adult Swiss patients living with this disease."

Swissmedic’s decision follows the recent European Union approval of Anzupgo which is valid in all European Member States, Iceland, Norway, and Liechtenstein.⁹ Regulatory filings in other markets are underway.

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 applications of Anzupgo compared with cream vehicle in the treatment of adults with moderate to severe CHE.^13-15

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 included 2 (mild), 3 (moderate), and 4 (severe).^13-15

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.^13-15

Subjects who completed 16 weeks of treatment with Anzupgo or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 Open-label, Multi-site Extension trial. The purpose of this extension trial was to evaluate the long-term safety of Anzupgo.¹⁶

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 oral alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.¹⁰

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. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.¹⁰

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.^12,17 CHE is one of the most common skin disorders of the hands, with a prevalence rate of approximately 4.7%.³ In a substantial number of patients, HE can develop into a chronic condition.¹⁸ 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.¹¹

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹⁹ with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.²⁰ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.²¹

About Anzupgo^® (delgocitinib) Cream

Anzupgo^® (delgocitinib) cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE.¹⁸ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹¹ Anzupgo is currently approved in the European Union and Switzerland for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. 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 delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. Information for healthcare professionals for Anzupgo^® (delgocitinib) cream. https://www.swissmedicinfo.ch/
2. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
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. Dresden, Germany. September 04-07. Poster presentation #3.
4. Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11-14 October. Poster Presentation #P0369.
5. Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11-14 October. Poster Presentation #P0395.
6. 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. San Diago, CA. March 8-12.
7. Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: 24-week Phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Late Breaking News Session. D1T01.1.
8. 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.
9. Anzupgo^® (delgocitinib) cream. Summary of Product Characteristics. LEO Pharma; October 2024.
10. 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.
11. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
12. 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.
13. 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/ct2/show/NCT04871711.
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 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.
15. 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.
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. 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.
18. 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.
19. 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.
20. 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.
21. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.

MAT-77612 November 2024