Sanofi and Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Eosinophilic Esophagitis (EoE) in Children
Shots:
- The CHMP has granted positive opinion on expanding Dupixent's approval for EoE to children (1-11yrs., 15kg), who are not adequately controlled by or intolerant to conventional therapies; final decision is anticipated soon. Dupixent is approved for EoE in adults & adolescents (≥12yrs.)
- The opinion was based on P-III (EoE KIDS) study showing significant histological remission at 16wks. in part A which maintained for up to 1yr in part B. Improvements in the frequency & severity of EoE symptoms were also observed
- The safety aligned with the known profile of Dupixent with similar long-term safety b/w part B & part A. Results were published in The New England Journal of Medicine
Ref: Globenewswire | Image: Sanofi & Regeneron
Related News:- Regeneron and Sanofi Report the EC’s Approval of Dupixent to Treat Chronic Obstructive Pulmonary Disease (COPD)
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
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.
