Sanofi pe­ti­tions FDA over 'mis­lead­ing' la­bel for ri­val flu vac­cine that failed to con­firm ben­e­fit

Sanofi is call­ing on the FDA to change the la­bels for CSL Lim­it­ed sub­sidiary Se­qirus’ flu vac­cines, which won ac­cel­er­at­ed ap­provals but have failed to con­firm clin­i­cal ben­e­fit.

In a crowd­ed flu vac­cine mar­ket, in which Sanofi’s flu busi­ness pulled in more than $2.8 bil­lion in 2021, two of Se­qirus’ flu vac­cines in­clude Flu­ad, which is an ad­ju­vant­ed sea­son­al aTIV vac­cine that won ac­cel­er­at­ed ap­proval in Nov. 2015, and Flu­ad Quadri­va­lent, which is a for­mu­la­tion of the orig­i­nal that won ac­cel­er­at­ed ap­proval via an sBLA in Feb. 2020.

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