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Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic Esophagitis (EoE) in Children as Young as 1 Year Old
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Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group TARRYTOWN, N.Y. and PARIS, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent® (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to
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- Roche Antiviral Drug Reduces Transmission in Late-stage Study [Yahoo! Finance][Yahoo! Finance]
- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) had its "outperform" rating re-affirmed by analysts at Royal Bank of Canada. They now have a $1,282.00 price target on the stock.[MarketBeat]
- Regeneron, SNY Win FDA Approval for a Broader Dupixent Label [Yahoo! Finance][Yahoo! Finance]
- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) had its "neutral" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $1,015.00 price target on the stock.[MarketBeat]
- Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) [Yahoo! Finance][Yahoo! Finance]
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- 9/5/24 - Form 4
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