Drugs / SOF/VEL/VOX
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2017-01-20 | “Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX)” gilead.com ↗ “has been fully validated and is now under assessment by the European Medicines Agency (EMA)” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2016-12-08 | “it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA )” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02533427 | Oct 2015 → Mar 2016 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
Press releases naming this drug 1 release
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 | SOF/VEL/VOX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02533427 ↗ |
| Route | Oral | “400/100/100 mg FDC tablet administered orally once daily” NCT02533427 ↗ |