FDA tees up a snap re­view for Dupix­ent as Sanofi, Re­gen­eron hunt 4th ap­proval for megablock­buster

With com­peti­tor af­ter com­peti­tor go­ing af­ter Dupix­ent for in­di­ca­tions such as atopic der­mati­tis, is it fi­nal­ly the drug’s turn to con­cede and drop? Well, if Sanofi and Re­gen­eron can help it, not even close.

The megablock­buster drug that Sanofi and Re­gen­eron have col­lab­o­rat­ed over is back be­fore the FDA, the com­pa­nies an­nounced ear­ly Mon­day — fol­low­ing the FDA ac­cept­ing an sBLA for a new in­di­ca­tion: eosinophilic esophagi­tis (EoE), a chron­ic in­flam­ma­to­ry dis­ease and al­ler­gic con­di­tion that can im­pact a per­son’s abil­i­ty to swal­low. As the phar­mas are look­ing to get ap­proval for the drug in pa­tients 12 and old­er, the FDA grant­ed Dupix­ent pri­or­i­ty re­view — an FDA des­ig­na­tion that speeds up the agency’s re­view process from nor­mal­ly a 10-month time­frame up to with­in 6 months. Sanofi and Re­gen­eron were giv­en a PDU­FA date of Au­gust 3rd.

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