Drugs / PENBRAYA
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed meningococcal meningitis 1 milestone | |||||
| Filed | US (FDA) | PENBRAYA | meningococcal meningitis | — | “This trial was followed by the FDA’s acceptance of PENBRAYA’s Biologics License Application (BLA) in December 2022.” pfizer.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Penbraya | — | 2025-01-20 | europa.eu ↗ |
| Approved | EU (EMA) | Penbraya | — | 2024-11-14 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07197762 | Nov 2025 → Dec 2026 expected | meningococcal infection | Emory University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-10-20 | Pfizer | Regulatory FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-10-20 | Pfizer | FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents pfizer.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PENBRAYA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07197762 ↗ |
| Modality | Vaccine | “PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y.” NCT07197762 ↗ |
| Route | Intramuscular | “This will be administered intramuscularly in the deltoid.” NCT07197762 ↗ |