BRIEF—FDA accepts Sanofi's meningitis vaccine for review

27 June 2019

The US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi’s MenQuadfi vaccine candidate to help prevent meningococcal meningitis.

Positive data from Phase II and Phase III studies forms part of the BLA, and the FDA has a target action date to decide on the application by April 25, 2020.

If approved, MenQuadfi will be available in a fully liquid presentation. It continues to be studied in trials in different parts of the world.



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