Delgocitinib Approved for Adults with Moderate to Severe CHE in Switzerland

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LEO Pharma announced today in a news release that Swissmedic, Switzerland’s national regulatory body, has granted marketing approval for delgocitinib (Anzupgo) cream. This topical therapy, a pan-Janus kinase (JAK) inhibitor, is specifically indicated for adults suffering from moderate to severe chronic hand eczema (CHE) who have had insufficient response to or cannot use topical corticosteroids.¹

This approval signifies an important advancement in CHE management as it is the first topical pan-JAK inhibitor to be approved in Switzerland specifically for the condition. “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 and international operations for LEO Pharma, in the release. “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." 

Key Clinic DELTA Program and DELTA FORCE

The Swissmedic approval was based on extensive evidence from LEO Pharma's phase 3 clinical trial program, which includes the DELTA 1, 2, and 3 trials. DELTA 1 and DELTA 2 trials were randomized, double-blind, vehicle-controlled studies that assessed the efficacy of twice-daily delgocitinib applications compared to a cream vehicle. The primary endpoint in these trials was the Investigator’s Global Assessment for Chronic Hand Eczema Treatment Success (IGA-CHE TS) at week 16, with treatment success defined as achieving an IGA-CHE score of 0 (clear) or 1 (almost clear) and showing at least a 2-step improvement from baseline. Key secondary endpoints included substantial reductions in itch and pain scores, and improvements in Hand Eczema Severity Index (HECSI) scores from baseline to week 16. Treatment-emergent adverse events during this period were closely monitored to assess safety.^2-4

Alongside this, the DELTA FORCE trial, a head-to-head study, compared delgocitinib with alitretinoin, the only other approved therapy in Switzerland for severe CHE in patients who fail to respond to topical corticosteroids. DELTA FORCE was a 24-week trial in which participants applied delgocitinib cream twice daily or took alitretinoin capsules once daily. This trial used HECSI score reduction from baseline to week 12 as its primary endpoint and continued treatment up to 24 weeks if participants showed favorable outcomes.⁵

“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, in the release. "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."

Conclusion

Delgocitinib’s approval introduces a topical therapy that effectively reduces symptoms in Swiss patients with CHE. As CHE remains a high-burden condition for patients and healthcare systems, the release states the addition of delgocitinib to the therapeutic arsenal underscores a shift toward targeted, non-systemic therapies that cater specifically to dermatological needs.

Understanding CHE

Chronic itch is a complex, relapsing condition defined by persistent or recurrent episodes lasting more than 3 months or relapsing at least twice yearly. The condition, which affects around 4.7% of the population, often leads to psychological distress, social isolation, and difficulty performing daily tasks due to symptoms like erythema, scaling, and hyperkeratosis. This substantial burden has been shown to affect career prospects and quality of life. Additionally, CHE’s fluctuating nature makes it challenging to manage, particularly as effective treatments were limited to potent corticosteroids and systemic agents.

References

1. LEO Pharma’s anzupgo (delgocitinib) cream achieves marketing approval in Switzerland. News Release. LEO Pharma. Published November 14, 2024. Accessed November 14, 2024. https://www.leo-pharma.com/media-center/news/2024-leo-pharma-anzupgo-cream-achieves-marketing-approval-in-switzerland
2. 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
3. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 2) (DELTA 2). ClinicalTrials.gov identifier: NCT04872101. Updated October 17, 2024. Accessed November 14, 2024. https://clinicaltrials.gov/study/NCT04872101
4. Gooderham M. 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: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.
5. A 24 weektrial to compare the efficacy and safety of delgocitinibcream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema. ClinicalTrials.gov. Identifier: NCT05259722. Updated April 9, 2025. Accessed November 14, 2024. https://clinicaltrials.gov/study/NCT05259722?term=NCT05259722&rank=1