Drugs / Meningococcal ABCWY
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | meningococcal meningitis | 2024-04-16 | “FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02285777 | Dec 2014 → Mar 2015 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-04-16 | GlaxoSmithKline | Regulatory GSK’s 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US Advisory Committee on Immunization Practices gsk.com ↗
ACIP voted to recommend that persons over 10 years old receive a single dose of Penmenvy as an alternative to separate administration of meningococcal serogroups A, C, W and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. |
| 2025-02-15 | GlaxoSmithKline | Regulatory Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. |
| 2024-04-16 | GlaxoSmithKline | Regulatory GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. |
| 2023-05-12 | GlaxoSmithKline | Results GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains gsk.com ↗
GSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the phase III trial (NCT04502693) evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. |
| 2023-03-14 | GlaxoSmithKline | Results GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-16 | GlaxoSmithKline | GSK’s 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US Advisory Committee on Immunization Practices gsk.com ↗ |
| 2025-02-15 | GlaxoSmithKline | Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY gsk.com ↗ |
| 2024-04-16 | GlaxoSmithKline | GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA gsk.com ↗ |
| 2023-05-12 | GlaxoSmithKline | GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains gsk.com ↗ |
| 2023-03-14 | GlaxoSmithKline | GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate gsk.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Meningococcal ABCWY | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02285777 ↗ |
| Known as | MenABCWY | “An investigational MenABCWY vaccine combining serogroup B antigens and a meningococcal ACWY CRM197-glycoconjugate vaccine (MenACWY-CRM) could provide protection against all 5...” PMID 30061029 ↗ Jul 2018 |
| Modality | Vaccine | “An investigational MenABCWY vaccine combining serogroup B antigens and a meningococcal ACWY CRM197-glycoconjugate vaccine (MenACWY-CRM) could provide protection against all 5...” PMID 30061029 ↗ Jul 2018 |