LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE)
Shots:
- China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical corticosteroids; decision expected in 2027
- NDA was based on P-III (DELTA China) trial assessing Anzupgo (BID) vs vehicle in 362 Chinese pts with mod. to sev. CHE for 16wks. followed by a 36wk. open-label period (ongoing), which met its 1EP, with improvement in CHE severity at Wk. 16
- Submission was also supported by data from the full Anzupgo clinical program, incl. results from DELTA 1,2 & 3, DELTA Force, as well as DELTA Teen trials
Ref: Leo Pharma | Image: Leo Pharma| Press Release
Related News:- LEO Pharma Reports Data from P-III Study of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)
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