PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi announced on Friday evening that the Food and Drug Administration (FDA), the American health authority, had authorized the use of its drug Dupixent for the treatment of patients aged 12 and more with eosinophilic esophagitis.
“With this approval, Dupixent becomes the first and only drug specifically indicated for the treatment of eosinophilic esophagitis in the United States,” Sanofi said in a statement.
In this indication, the FDA agreed at the beginning of April to grant priority review to Dupixent. Priority review is granted by the FDA to drugs that have the potential to significantly improve the diagnosis, treatment, or prevention of serious diseases.
Also in this same indication, an application for approval of Dupixent is currently under review by the European Medicines Agency and regulatory submissions elsewhere in the world are also expected by the end of 2022.
Eosinophilic esophagitis is a chronic, progressive disease with a type 2 inflammatory signature that causes lesions in the esophagus and causes difficulty in swallowing. In the United States, this disease affects approximately 160,000 people on treatment, of whom approximately 48,000 have experienced multiple treatment failures.
Dupixent has been jointly developed by Sanofi and Regeneron for over ten years under a global collaboration agreement. More than 400,000 patients with certain forms of atopic dermatitis, asthma and naso-sinus polyposis have been treated with this medicine worldwide.
At the end of March, Sanofi increased its sales target for Dupixent to more than 13 billion euros at cruising speed.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: VLV
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May 23, 2022 01:10 ET (05:10 GMT)