Bexsero

Drug Overview

Bexsero (multicomponent meningococcal serogroup B vaccine; GlaxoSmithKline) is a multicomponent meningococcal serogroup B vaccine. It is approved for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in adolescents and young adults from 10 years through to 25 years of age in the US, and in individuals two months of age and older in the EU. Bexsero contains three surface-exposed recombinant proteins: factor H binding protein, Neisseria adhesin A, and Neisseria heparin-binding antigen. It also includes New Zealand strain outer membrane vesicles. The antibodies generated after immunization with Bexsero target the aforementioned surface proteins present on the outer membrane vesicles.

Bexsero is one of two serotype B meningococcal vaccines approved in the EU and US markets. Following its incorporation into the US, Italian, and UK vaccination schedules throughout 2015 and 2016, Bexsero’s sales have risen rapidly in these markets, and continue to grow with the gradual uptake in key risk groups. However, in France, Germany, and Spain, Bexsero is only reimbursed for very small populations at high risk of IMD due to uncertainties regarding its real-world benefit and poor cost effectiveness. It is unlikely that Bexsero will be incorporated into the immunization schedules of these EU markets unless GlaxoSmithKline offers substantial discounts and gathers real-world data to clearly demonstrate a reduction in the serogroup B IMD burden, ideally with an accompanying herd immunity benefit by reducing nasal carriage. In the long term, GlaxoSmithKline intends to position its pipeline vaccine MenABCW-135Y (pentavalent meningococcal conjugate vaccine) as a successor to Bexsero and Menveo (quadrivalent oligosaccharide diphtheria CRM-197 conjugate vaccine) in persons aged ≥10 years, although the combined vaccine’s launch is not expected until 2022.

In 2018, GlaxoSmithKline initiated a Phase III study for Bexsero in US infants aged six weeks to 12 months, and given the high cost and high coverage rates seen for meningococcal serotype B (MenB) vaccines in the infant population, an indication expansion for use in infants would be a lucrative next step for Bexsero in the US. In Italy and the UK, the introduction of MenB vaccination into the routine infant immunization schedule drove significant sales growth.