• 18 Nov 2024
• Admin
• News Article

LEO Pharma’s Anzupgo Cream to Treat Chronic Hand Eczema Receives Marketing Approval in Switzerland

LEO Pharma’s Anzupgo cream to treat chronic hand eczema receives marketing approval in Switzerland

Overview

LEO Pharma A/S, a global leader in medical dermatology, 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.

About Anzupgo

• 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.

From the EVP: LEO Pharma

• “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."  

Trial Behind Approvals 

• 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.  
• 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. 
• 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.  

From LEO Pharma: Switzerland and Austria

• “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. Regulatory filings in other markets are underway.

Objective of Trial

• 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.
• Primary endpoint- 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).
• Secondary endpoints- 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.

Treatment with Anzupgo (Twice Daily)

• 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.

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.
• 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.

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

All About the Cream: 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. 
• The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 
• 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.