Shots:
- The US FDA has accepted LEO Pharma‘s sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU
- sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE for whom topical corticosteroids are inadequate or inappropriate
- The trial met its 1EP of improved IGA-CHE TS at Wk. 16 & also achieved its key 2EP; data was presented at the EADV’25
Ref: Businesswire | Image: LEO Pharma | Press Release
Related News: LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus
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