Drug Overview
GlaxoSmithKline’s MenABCW-135Y is a pentavalent meningococcal conjugate vaccine for the A, B, C, W-135, and Y meningococcal strains. With all of the vaccine’s announced Phase II trials now complete, the author expects that Phase III trials could start by the end of 2019, and forecasts US and EU approvals in adolescents and adults to occur as early as 2022.
Following its anticipated approvals in the US and EU in 2022, MenABCW-135Y is expected to replace marketed vaccines Bexsero (multi component meningococcal serogroup B vaccine; GlaxoSmithKline) and Menveo (quadrivalent oligosaccharide diphtheria CRM-197 conjugate vaccine; GlaxoSmithKline) on the market if it is able to demonstrate non-inferior immunogenicity in persons aged ≥10 years. MenABCW-135Y’s broad serotype coverage positions it well to replace Bexsero and Menveo in markets where both of the aforementioned products are reimbursed, as it would be the first meningococcal vaccine on the market to cover all of the major disease-causing serotypes: A, B, C, W, and Y. Thus far, MenABCW-135Y has demonstrated non-inferior immunogenicity to Menveo in Phase II trials, but it will also need to demonstrate non-inferior immunogenicity against serotype B when compared to Bexsero if it hopes to successfully cannibalize Bexsero’s and Menveo’s market shares.
GlaxoSmithKline’s MenABCW-135Y is a pentavalent meningococcal conjugate vaccine for the A, B, C, W-135, and Y meningococcal strains. With all of the vaccine’s announced Phase II trials now complete, the author expects that Phase III trials could start by the end of 2019, and forecasts US and EU approvals in adolescents and adults to occur as early as 2022.
Following its anticipated approvals in the US and EU in 2022, MenABCW-135Y is expected to replace marketed vaccines Bexsero (multi component meningococcal serogroup B vaccine; GlaxoSmithKline) and Menveo (quadrivalent oligosaccharide diphtheria CRM-197 conjugate vaccine; GlaxoSmithKline) on the market if it is able to demonstrate non-inferior immunogenicity in persons aged ≥10 years. MenABCW-135Y’s broad serotype coverage positions it well to replace Bexsero and Menveo in markets where both of the aforementioned products are reimbursed, as it would be the first meningococcal vaccine on the market to cover all of the major disease-causing serotypes: A, B, C, W, and Y. Thus far, MenABCW-135Y has demonstrated non-inferior immunogenicity to Menveo in Phase II trials, but it will also need to demonstrate non-inferior immunogenicity against serotype B when compared to Bexsero if it hopes to successfully cannibalize Bexsero’s and Menveo’s market shares.
Table of Contents
OVERVIEW- Drug Overview
- Product Profiles
- MenABCW-135Y : Meningococcal vaccines
LIST OF TABLES
Table 1: MenABCW-135Y drug profile
Table 2: Late-phase trials of MenABCW-135Y for meningococcal vaccination
Table 3: MenABCW-135Y for meningococcal disease – SWOT analysis
