GSK-3536819
GSK plc’s 5-in-1, first-generation GSK-3536819 vaccine candidate targets the five groups of the bacteria N. meningitidis (A, B, C, W and Y; MenABCWY) that cause most invasive meningococcal disease (IMD) cases globally. It combines the antigenic components of the company’s already licensed meningococcal vaccines, BEXSERO (meningococcal group B [MenB]) and MENVEO (MenACWY), both of which are well established with demonstrated efficacy and safety profiles.
About GSK-3536819
- GSK plc
- Recombinant protein, outer membrane vesicle (OMV), conjugated, pentavalent vaccine targeting the five groups of the bacteria N. meningitidis (A, B, C, W and Y)
- Two-dose intramuscular injection administered six months apart for active immunization of individuals aged 10-25 years
- 563m estimated MenABCWY vaccine-eligible individuals in the G7 markets in 2024
- ~600 incident new cases of invasive meningococcal disease (IMD) in the G7 markets in 2024
Why is it a drug to watch?
The combination of the separate MenB and MenACWY vaccines into one reduces the number of injections required to receive the same level of protection, potentially improving coverage and compliance with the vaccination schedule.
Although second to market after Pfizer Inc’s pentavalent PENBRAYA™ vaccine, GSK-3536819 has the advantage of approval of BEXSERO in the E.U. for individuals from the age of 2 months old, while PENBRAYA is limited by approval of Trumenba® starting at the age of 10 years. This could result in a greater population eligible for vaccination with GSK-3536819 in the E.U. These multivalent vaccines could help support the WHO’s strategy to eradicate meningitis by 2030.
GSK-3536819 was non-inferior (for all five serogroups) and had a similar safety profile to BEXSERO and MENVEO (control group) in terms of eliciting an immune response in the:
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Pivotal global phase 3 trial, in which the vaccine was administered in two doses (day 1 and day 181) to 3,650 healthy individuals aged 10-25 years. This also served as the confirmatory trial for BEXSERO. In this trial, the vaccine was effective against 110 diverse meningitis B invasive strains.
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Phase 3B clinical trial with 1,247 healthy individuals aged 15-25 years who were previously vaccinated with MENVEO (day 1 and day 181), where GSK-3536819 was administered on day 211. One dose of MENVEO on Day 1 and two doses of BEXSERO on Day 181 and Day 211 acted as the active comparator.
Review and approval status
April 2024
BLA accepted: U.S. FDA
February 14, 2025
PDUFA date
Actual and expected launch:
- 2024: United States
- 2025: European Union, United Kingdom
Patents estimated to expire beginning in 2012
Drug Timeline & Success Rates
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of October 31, 2024
How will GSK-3536819 impact the market for meningococcal disease prevention?
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GSK-3536819 will compete with PENBRAYA, the first and only approved pentavalent vaccine against the same five serogroups (A, B, C, W, and Y), as well as currently licensed MenACWY vaccines: MENVEO, MenQuadfi® (Sanofi) and NIMENRIX® (Pfizer Inc).
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The simplified dosing schedule offered by PENBRAYA and GSK-3536819 is viewed favorably by physicians, and there is expected to be room in the market for both products.
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The use of the separate ACWY and B vaccines from both companies is anticipated to decline as the pentavalent versions become more widespread.
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Sales of both BEXSERO (available in >50 countries) and MENVEO (available in >60 countries) increased in 2023, by 14% to £849m and 12% to £380m, respectively.3 It is possible that some of these sales, and the growth, could transfer to GSK-3536819 once it is launched.
What gaps in treatment does GSK-3536819 fill?
Although rare, IMD is a serious illness that can result in long-term consequences such as brain damage or amputations, life-threatening complications or death, primarily in children and adolescents. GSK-3536819 provides another option, in addition to Pfizer Inc’s PENBRAYA, to protect against the five major serogroups that account for nearly all IMD cases globally. The drug eliminates the need to be vaccinated twice and reduces the total number of injections to only two. This could increase compliance with vaccination and encourage greater coverage across the at-risk population.
What hurdles might it need to overcome to reach blockbuster status?
Low disease awareness can lead to poor vaccination rates; for example, only approximately 31% of adolescents in the U.S. have received a meningococcus B vaccine, and <12% have received both required doses.4 PENBRAYA has the advantage of being the first pentavalent (A, B, C, W, and Y) meningococcal vaccine approved and available for individuals aged 10-25 years in the U.S. market for more than a year (September 2023). Even if approved worldwide, GSK-3536819 might experience slow uptake in some areas because it is more expensive than the monovalent vaccines that are available against the most prevalent strains in limited-resource countries and regions.
