Regeneron Receives EMA’s CHMP Positive Opinion Recommending Expanded Approval of Dupixent (dupilumab) for Atopic Dermatitis
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending expanded approval for Dupixent to treat sev. AD. The EC’s final decision is expected in the coming months
- The opinion was based on the P-III trial results evaluating Dupixent (200/300mg, q4w) added to SoC low-potency TCS vs low-potency TCS alone in 162 children aged 6mos. to 5yrs.
- The trial met all 1EPs & 2EPs i.e., Dupixent + low-potency TCS showed improvement in skin clearance & reduced overall disease severity @16wks., reduction in itch & skin pain along with improved sleep quality & health-related QoL while the Long-term data showed a sustained improvement in the disease measures @~1yr. & the safety results were consistent with the known safety profile of Dupixent
Ref: Globe Newswire | Image: Regeneron
Related Post:- Regeneron Receives EMA’s CHMP Positive Opinion Recommending Approval of Dupixent (dupilumab) for Eosinophilic Esophagitis
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
