Delgocitinib Cream Approved in Switzerland for Chronic Hand Eczema
核心洞察
Swissmedic has approved delgocitinib (Anzupgo) cream, a topical pan-JAK inhibitor, for adults with moderate to severe chronic hand eczema (搜索) (CHE) who have had an inadequate response to topical corticosteroids.
The approval was based on the DELTA phase 3 clinical trial program, which demonstrated the efficacy and safety of delgocitinib compared to a vehicle cream in reducing CHE symptoms.
A head-to-head DELTA FORCE trial showed delgocitinib's effectiveness against alitretinoin, the only other approved therapy in Switzerland for severe CHE, highlighting its potential as a new treatment option.
LEO Pharma's delgocitinib (Anzupgo) cream has received marketing approval from Swissmedic, Switzerland’s national regulatory body, for the treatment of moderate to severe chronic hand eczema (搜索) (CHE) in adults who have not responded adequately to topical corticosteroids. This approval marks delgocitinib as the first topical pan-Janus kinase (搜索) (JAK) inhibitor approved for CHE in Switzerland, offering a new treatment option for a condition that significantly impacts patients' quality of life. The approval is based on data from the DELTA phase 3 clinical trial program, including head-to-head data versus the current standard of care.
Clinical Trial Data Supporting Approval
The Swissmedic approval was supported by data from the DELTA 1, 2, and 3 trials, as well as the DELTA FORCE trial. The DELTA 1 and DELTA 2 trials were randomized, double-blind, vehicle-controlled studies evaluating the efficacy of twice-daily delgocitinib applications compared to a vehicle cream. The primary endpoint was the Investigator’s Global Assessment for Chronic Hand Eczema (搜索) Treatment Success (IGA-CHE TS) at week 16, with treatment success defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) and 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.
The DELTA FORCE trial compared delgocitinib with alitretinoin, the only other approved therapy in Switzerland for severe CHE in patients who fail to respond to topical corticosteroids. This 24-week trial used HECSI score reduction from baseline to week 12 as its primary endpoint. Participants applied delgocitinib cream twice daily or took alitretinoin capsules once daily.
Impact on Chronic Hand Eczema Treatment
Chronic hand eczema (搜索) affects approximately 4.7% of the population and is characterized by persistent or recurrent episodes lasting more than 3 months, or relapsing at least twice yearly. Symptoms include erythema, scaling, and hyperkeratosis, which can lead to psychological distress, social isolation, and difficulty performing daily tasks. The fluctuating nature of CHE makes it challenging to manage, particularly as effective treatments were previously limited to potent corticosteroids and systemic agents.
"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."
With the approval of delgocitinib, Swiss patients with moderate to severe CHE now have access to a targeted, non-systemic therapy that has demonstrated efficacy in clinical trials, offering a potential improvement in their quality of life.