Drug Overview
Sanofi’s MenQuadfi (quadrivalent polysaccharide tetanus toxoid conjugate vaccine) is a second-generation active polyvalent conjugate vaccine against group A, C, Y, and W meningococcal infection. It is presented as a sterile solution for injection containing Neisseria meningitidis capsular polysaccharide antigens individually conjugated to tetanus toxoid protein. Sanofi has submitted a Biologics License Application (BLA) for MenQuadfi to the US Food and Drug Administration (FDA) with a target action date of April 2020.
The author expects a subsequent launch for persons aged ≥2 years in Q3 2020. The vaccine is currently in Phase III development in the EU. Following the initiation of the first of Sanofi's Phase III studies in July 2016, the author forecasts the vaccine’s EU approval in individuals aged ≥12 months in Q3 2020, based on the expected submission timeline, with a launch date between Q4 2020 and Q1 2021. Sanofi also expects to file for an indication expansion in the US and EU in the upcoming years to include infants as young as six weeks old.
Sanofi’s MenQuadfi (quadrivalent polysaccharide tetanus toxoid conjugate vaccine) is a second-generation active polyvalent conjugate vaccine against group A, C, Y, and W meningococcal infection. It is presented as a sterile solution for injection containing Neisseria meningitidis capsular polysaccharide antigens individually conjugated to tetanus toxoid protein. Sanofi has submitted a Biologics License Application (BLA) for MenQuadfi to the US Food and Drug Administration (FDA) with a target action date of April 2020.
The author expects a subsequent launch for persons aged ≥2 years in Q3 2020. The vaccine is currently in Phase III development in the EU. Following the initiation of the first of Sanofi's Phase III studies in July 2016, the author forecasts the vaccine’s EU approval in individuals aged ≥12 months in Q3 2020, based on the expected submission timeline, with a launch date between Q4 2020 and Q1 2021. Sanofi also expects to file for an indication expansion in the US and EU in the upcoming years to include infants as young as six weeks old.
Table of Contents
OVERVIEW- Drug Overview
- Product Profiles
- MenQuadfi : Meningococcal vaccines
LIST OF TABLES
Table 1: MenQuadfi drug profile
Table 2: Late-phase trials of MenQuadfi for meningococcal vaccination
Table 3: MenQuadfi for meningococcal vaccination – SWOT analysis
