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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