CSLLY - Sanofi asks FDA to change labeling of Seqirus flu vaccines over lack of confirmatory benefit

Sanofi (SNY -0.0%) has filed a Citizen Petition with the FDA asking the agency to change the labeling of Seqirus' Fluad flu vaccines as a confirmatory post-market study failed to confirm clinical benefit. The Fluad vaccine was approved under the FDA's accelerated approval pathway in 2015. That required Seqirus, which is part of CSL Limited (OTCPK:CSLLY -2.6%), to conduct a trial to confirm the vaccine's benefit. "Petitioner requests that the labeling for these products, both of which received accelerated approval, contain a description of the limitations of existing evidence, including a description of results from an absolute efficacy confirmatory study that failed to meet its primary efficacy endpoints," Sanofi wrote in its petition. Seqirus told Endpoints News that in February, the CDC's Advisory Commission on Immunization Practices said that there are benefits of enhanced influenza vaccines -- such as Seqirus Quadrivalent -- compared to egg-based influenza shots. In 2021, Sanofi (NASDAQ:SNY)

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Sanofi asks FDA to change labeling of Seqirus flu vaccines over lack of confirmatory benefit