- Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY Phase 3 trial of Dupixent (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks.
- EoE is a chronic inflammatory disease that damages the esophagus and prevents it from working correctly.
- 68% of children on a higher dose and 58% of patients on a lower dose of Dupixent achieved histological disease remission compared to 3% of children on placebo.
- Related: FDA Accepts Regeneron, Sanofi's Filing For Review In Skin Disease.
- Children receiving the higher dose of Dupixent experienced an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline at week 16 compared to a 21% increase for placebo.
- 0.88 and 0.84 reductions from baseline in disease severity and extent, respectively, than a 0.02 and 0.05 increase for placebo.
- 3.5-point reduction in abnormal endoscopic findings from baseline compared to a 0.3-point increase for placebo.
- In May 2022, the FDA approved Dupixent 300 mg weekly for EoE patients aged 12 years and above.
- Price Action: SNY stock is down 2.01% at $48.81 during the premarket session on Thursday's last check. REGN shares closed at $602.02 on Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in