LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)
Shots:
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
