Drugs / E/C/F/TAF
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | HIV infectious disease | 2014-12-23 | “A Marketing Authorization Application (MAA) in the European Union for E/C/F/TAF was fully validated on December 23, 2014 .” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-05 | “Gilead filed a New Drug Application for E/C/F/TAF with the U.S. Food and Drug Administration on November 5, 2014.” gilead.com ↗ “Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration ( FDA ) for E/C/F/TAF” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02600819 | Dec 2015 → Sep 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2015-02-26 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF) gilead.com ↗
A second analysis found that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild. |
| 2014-11-06 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV gilead.com ↗ |
All press releases naming this drug 3 releases
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 | E/C/F/TAF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02600819 ↗ |
| Route | Oral | “150/150/200/10 mg FDC tablets administered orally once daily” NCT02600819 ↗ |