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 | “Gilead's MAA for E/C/F/TAF was validated on December 23, 2014.” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-06 | “today announced that 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 3 | NCT01818596 | Mar 2013 → Jul 2014 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
In an open-label study evaluating the pharmacokinetics, safety, and efficacy of switching to once-daily Biktarvy in virologically suppressed pregnant women with HIV, Biktarvy was generally well tolerated and all participants maintained virologic suppression at delivery (HIV-1 RNA <50 copies/mL; n=32). |
| 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 ↗ |
| 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 4 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 NCT01818596 ↗ |
| Route | Oral | “administered orally once daily with food” NCT01818596 ↗ |