Sanofi and Regeneron’s blockbuster Dupixent rejected by FDA for chronic hives condition

US reg­u­la­tors want to see more ef­fi­ca­cy da­ta be­fore they con­sid­er ap­prov­ing Sanofi and Re­gen­eron’s Dupix­ent in a skin con­di­tion char­ac­ter­ized by chron­ic hives, Sanofi an­nounced Fri­day.

The an­ti-in­flam­ma­to­ry megablock­buster was hand­ed a re­jec­tion in chron­ic spon­ta­neous ur­ticaria (CSU), a con­di­tion with a pa­tient pop­u­la­tion that ex­ec­u­tives have said is “close to the size” of Dupix­ent’s mar­ket in COPD. The com­plete re­sponse let­ter did not cite any safe­ty or man­u­fac­tur­ing is­sues, ac­cord­ing to Sanofi, but it did make clear that “ad­di­tion­al ef­fi­ca­cy da­ta are re­quired to sup­port an ap­proval.”

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