PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi announced on Monday that the Food and Drug Administration (FDA), the American health authority, had agreed to grant a priority review to its drug Dupixent for the treatment of patients with 12 years and older with eosinophilic esophagitis.
“The FDA is expected to render its decision on this investigational indication on August 3, 2022,” Sanofi said in a statement.
Priority review is granted by the FDA to drugs that have the potential to significantly improve the diagnosis, treatment, or prevention of serious diseases.
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 drug worldwide.
-Julien Marion, Agefi-Dow Jones; +33 (0)1 41 27 47 94; [email protected] ed: DID
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April 04, 2022 01:26 ET (05:26 GMT)