BALLERUP, 28. October 2024 – In 1908, LEO Pharma A/S – then “Løvens Kemiske Fabrik” – launched new treatments for Danish patients for the first time.

Today, 116 years later, the Danish company, which today is a global leader in medical dermatology, announces the launch of a new product in Denmark, Anzupgo® (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema where topical corticosteroids are inadequate or inappropriate. ¹

”Today is an important milestone for us at LEO Pharma. Chronic Hand Eczema 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. Historically, Chronic Hand Eczema has been an overlooked disease in many countries – but in Denmark, the problem has been recognized for a long time among dermatologists. That is why we are very proud that we in Denmark, as a second country in the world, can introduce a new alternative to a patient group with such a high unmet need for more treatment options,” said Anja Verhaug, General Manager for LEO Pharma Nordics.

Chronic Hand Eczema (CHE) is a heterogeneous and variable skin disease that causes inflammation and whose symptoms include itching and pain. The underlying cause of the disease is that the skin's protection does not work as it should, inflammation in the skin and changes in the microorganisms that live on the skin. ² The condition can have a large impact on one's mental health, social life and work functioning. ^4-6

”CHE can greatly affect everyday life. Not only in relation to itch and pain, which in itself is hard to live with – but also in relation to what the disease can make difficult. It can be cooking or cleaning – but also shaking hands when you meet new people. There are people who don't feel they can touch their children. People who have to give up their jobs because their hands can't take it. When I speak to dermatologists in Denmark, many say that they have been waiting a long time for alternative treatments for patients with CHE where topical corticosteroids are inadequate or inappropriate. That is why today is a big day for LEO Pharma,” said Alexander Egeberg, Head of Global Medical Affairs hos LEO Pharma A/S.

With the launch, Denmark will become the second country in the world where Anzupgo® will be available, after the product was approved by the European regulatory authorities in September 2024.¹ Launches in more European countries will follow, and LEO Pharma has also applied for marketing authorization in other countries outside the EU.

LEO Pharma will subsequently initiate a process with the Danish Medicines Agency for the purpose of obtaining reimbursement for the treatment.

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.^13,14 In a substantial number of patients, HE can develop into a chronic condition.¹⁵ CHE is one of the most common skin disorders of the hands, with a prevalence rate of approximately 4.7% ³ 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.⁴

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,⁵ 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.¹⁶ Furthermore, work and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁷

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 signaling, 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.³ Anzupgo is currently approved in the European Union 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.

References

1. Anzupgo® (delgocitinib) creme. Produktresumé. LEO Pharma; September 2024. 
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; September 04-07 2024; Dresden, Germany. Poster presentation #3 
4. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378. 
5. 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. 
6. Thyssen JP, Silverberg JI, Guttman-Yassky E. Chronic hand eczema understanding has ramifications on clinical management. J Eur Acad Dermatol Venereol. 2020;34(8):e429-e430. 
7. 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.  
8. 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.  
9. 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. 
10. 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. 
11. 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. 
12. 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.  
13. 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 
14. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.  
15. 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. 
16. 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. 
17. 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. 
18. 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. 

MAT-77450 Oktober 2024