LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)
Shots:
- The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids
- Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which met their 1EP, with ≥2-point improvement in IGA-CHE TS at Wk. 16 (20% vs 10% & 29% vs 7%)
- Both DELTA 1 & 2 trials met their 2EPs, with 49% pts in each achieving ≥4-point HESD pain score reduction vs 28% & 23% as well as 47% pts in each achieving ≥4-point itch score reduction vs 23% & 20% at Wk. 16
Ref: Businesswire | Image: Leo Pharma| Press Release
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