Home » EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis
EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis
Drugs Submissions and Approvals
The European Commission (EC) has expanded its marketing authorization for Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) to treat adults and adolescents 12 years and older with eosinophilic esophagitis who weigh at least 88 pounds and cannot take conventional therapy.
The decision was supported by positive 52-week data from a phase 3 clinical trial, in which approximately 60 percent of participants achieved remission compared with about five percent of those given a placebo.
Dupixent’s expanded authorization in the EU means the drug is now indicated for treatment of five diseases with underlying type 2 inflammation.