European Commission approves Dupixent for eosinophilic esophagitis

The European Commission has expanded the marketing authorization for Sanofi and Regeneron's Dupixent (dupilumab) in the European Union to include the treatment of eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg. The medication is intended for patients who are inadequately controlled by, intolerant to, or not candidates for conventional therapy.

EoE is a chronic inflammatory disease that damages the esophagus, hindering its normal function. With this approval, Dupixent becomes the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S. The condition affects an estimated 50,000 adults and adolescents in the EU with severe, uncontrolled EoE.

Pivotal trial data showed that approximately 60% of patients treated with Dupixent achieved histological disease remission and significant improvement in swallowing ability compared to placebo. "This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union," said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron.

The drug is now approved to treat five diseases with underlying type 2 inflammation in the EU. "The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the esophagus can make something as simple as eating a painful and distressing experience," noted Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi. "With this latest approval, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option."