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FDA accepts Dupixent supplemental biologics licence for EoE treatment

The US-biotech major Regeneron Pharmaceuticals and French-drugmaker Sanofi SA has jointly said that the FDA has accepted their priority review application for a supplemental biologics licence for Dupixent 300 mg. The companies expressed delight at the developments as there are currently no FDA-approved medicines for eosinophilic esophagitis and added that the review will be undertaken for adults and children aged 12 years and older with eosinophilic esophagitis. The companies also pointed out that the positive clinical data from the trials of the drug, where dupilumab at 24 weeks significantly improved signs and symptoms of EoE, including ability to swallow and eosinophil counts in the oesophagus as compared to the placebo.

Content by Future Medicine

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