LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE) 

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• The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by topical corticosteroids 

• Opinion was based on P-III (DELTA 1 & DELTA 2) trials assessing the safety & efficacy of Anzupgo (BID) vs vehicle for moderate to severe CHE. Those who concluded treatment for 16wks. were rolled over to 36wk. DELTA 3 extension study to assess long-term safety 

• The DELTA 1 & 2 reached their 1EPs & 2EPs, with DELTA 3 trial showing the long-term safety that aligned with prior outcomes. The approval, if granted, would applicable across the whole EU plus Iceland, Norway & Liechtenstein; regulatory filings with other bodies are ongoing 

Ref: LEO Pharma  | Image: LEO Pharma  | Press Release

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