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 | “The MAA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg...” gilead.com ↗ “An MAA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg...” gilead.com ↗ “MAAs in the European Union were fully validated on December 23, 2014 , and August 20, 2015, for E/C/F/TAF and R/F/TAF, respectively.” gilead.com ↗ “A Marketing Authorization Application (MAA) in the European Union for E/C/F/TAF was fully validated on December 23, 2014 .” gilead.com ↗ “Gilead's MAA for E/C/F/TAF was validated on December 23, 2014 .” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-05 | “In November 2014 , Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration ( FDA ) for E/C/F/TAF” gilead.com ↗ “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 has submitted New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-04-29 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗ |
| 2015-09-02 | Gilead Sciences | Results Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection met its primary objective. |
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 NCT06337032 ↗ |
| Route | Oral | “150/150/200/10 mg tablet administered orally” NCT06337032 ↗ |