Fluzone Maker Sanofi Wants Language On Failed Confirmatory Study Added To Seqirus’ Fluad Label

In new twist on debate over ‘dangling’ accelerated approvals, Sanofi wants Fluad label to reflect failure of confirmatory trial to meet primary efficacy endpoint; Seqirus says Sanofi is trying to interfere with ACIP’s possible preferential recommendation of enhanced seasonal flu vaccines in elderly.

Missed target
Sanofi wants a competitor's labeling to disclose a missed primary efficacy endpoint in a confirmatory trial. • Source: Alamy

Seasonal influenza vaccine manufacturer Sanofi is attempting to leverage a failed confirmatory trial for Seqirus’ Fluad to its competitive advantage, requesting the US Food and Drug Administration revise Fluad labeling to reflect limitations of the vaccine’s existing efficacy evidence.

In a citizen petition submitted to the FDA on 2 March, Sanofi requests that labeling for Fluad and Fluad...

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