Drugs / Herpes Zoster
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Shingrix | herpes zoster | 2022-06-28 | “today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Shingrix” gsk.com ↗ |
| Filed | Japan (PMDA) | Shingrix | herpes zoster | 2017-04-18 | “submitted a New Drug Application in Japan seeking approval for the candidate shingles vaccine, Shingrix, for the prevention of herpes zoster” gsk.com ↗ |
| Filed | US (FDA) | Shingrix | herpes zoster | 2016-10-24 | “it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA)” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT02868970 | Feb 2017 → Jul 2021 | — | Canadian Immunization Research Network | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023 gsk.com ↗
Virological suppression in people with HIV-1 (PWH) receiving dolutegravir/lamivudine was high and similar across age groups despite older PWH having increased rates of comorbidities and polypharmacy (TANDEM subgroup analysis) (encore) |
| 2022-10-12 | GlaxoSmithKline | Results GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗
Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy, Immuno and Safety Results at Approximately 10 Years after Initial Vaccination |
| 2016-11-25 | GlaxoSmithKline | Regulatory GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - Follows regulatory submissions in US and Canada gsk.com ↗
The regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. |
| 2014-12-18 | GlaxoSmithKline | Results Pivotal phase III study of GSK shingles candidate vaccine meets its primary endpoint gsk.com ↗
Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-10 | GlaxoSmithKline | GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023 gsk.com ↗ |
| 2022-10-12 | GlaxoSmithKline | GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗ |
| 2017-09-13 | GlaxoSmithKline | FDA Advisory Committee votes unanimously for Shingrix (HZ/su) in the US for prevention of herpes zoster (shingles) in adults ages 50 and over gsk.com ↗ |
| 2016-11-25 | GlaxoSmithKline | GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - Follows regulatory submissions in US and Canada gsk.com ↗ |
| 2014-12-18 | GlaxoSmithKline | Pivotal phase III study of GSK shingles candidate vaccine meets its primary endpoint gsk.com ↗ |
| 2010-08-22 | GlaxoSmithKline | GSK commences Phase III clinical trials to develop herpes zoster vaccine for the prevention of shingles gsk.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Herpes Zoster | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02868970 ↗ |
| Modality | Vaccine | “Herpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles).” NCT02868970 ↗ |