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.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER