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Sanofi Says FDA To Review Meningococcal Vaccine Candidate MenQuadfi

French pharma major Sanofi (SNYNF,SNY) announced Thursday that the U.S. Food and Drug Administration has accepted for review the Biologics License Application or BLA for MenQuadfi, a meningococcal vaccine candidate. The target action date for the FDA decision is April 25, 2020.

The company noted that the BLA is for MenQuadfi Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis.

Sanofi's recently submitted BLA includes positive data from Phase II and Phase III clinical trials held in the U.S. to seek an indication for use of the vaccine in persons 2 years of age and older. If approved, MenQuadfi will be available in a fully liquid presentation.

The company has performed Phase II and Phase III trials in the U.S., the European Union, Asia and Latin America. Sanofi is conducting additional Phase III trials in these same regions and Africa.

MenQuadfi's safety and efficacy data have not yet been evaluated by any regulatory authority.

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