1. Pink Sheet

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

 
• By Sue Sutter

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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