Regeneron Receives EMA’s CHMP Positive Opinion Recommending Approval of Dupixent (dupilumab) for Eosinophilic Esophagitis
- The EMA’s CHMP has adopted a positive opinion recommending approval of Dupixent for adults and adolescents with EoE. The EC’s decision is expected in the coming months
- The opinion was based on the 52wk. results from a P-III trial consisting of 3 parts (Part A in 81 patients), Part B (240 patients) & Part C evaluating Dupixent (300mg, qw) vs PBO for 24wks.
- The results showed an improvement in the ability to swallow as early as 4wks. as well as histological disease remission, improvements in abnormal endoscopic findings of the esophagus & cellular improvements @24wks. with outcomes maintained ~1yr. The safety results were consistent with the known safety profile of Dupixent in its approved indications
Ref: PRNewswire | Image: Regeneron
Related News:- Regeneron Receives EMA’s CHMP Positive Opinion of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis
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 [email protected].