Swissmedic, Switzerland’s national regulatory agency for therapeutic products, has granted marketing approval to Leo Pharma’s Anzupgo (delgocitinib cream) 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.

Delgocitinib cream is the first topical pan-Janus kinase (JAK) inhibitor to be approved in Switzerland specifically for moderate to severe CHE. Swissmedic’s decision follows the recent European Union approval of delgocitinib cream which is valid in all European Member States, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway. Following the recent European Commission approval, Germany became the first country worldwide where Delgocitinib cream was made available. The cream is fast-tracked by the U.S. Food and Drug Administration  for chronic hand eczema

“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,” says Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma, in a news 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.” 

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

In line with the approval in the European Union, the marketing approval of delgocitinib cream 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 delgocitinib cream 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 delgocitinib cream compared with oral alitretinoin capsules. Alongside delgocitinib cream, alitretinoin is the only other treatment currently approved in Switzerland to specifically treat severe CHE in patients who do not respond to topical corticosteroids. 

“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,” adds 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.”