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 | 2014-11-05 | “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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01780506 | Dec 2012 → Aug 2014 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2018-12-04 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-02-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
| 2015-07-21 | Gilead Sciences | Results Gilead Announces Phase 3 Results From the First Study to Evaluate Switching From TDF-Based Regimens to a TAF-Based Regimen Containing Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide (E/C/F/TAF) gilead.com ↗
The rates of virologic failure were similar between the two arms (E/C/F/TAF, 1.0 percent; TDF-based regimen, 1.3 percent). |
| 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. |
| 2014-09-24 | Gilead Sciences | Results Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies gilead.com ↗ |
All press releases naming this drug 7 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 NCT01780506 ↗ |
| Route | Oral | “150/150/200/10 mg FDC tablet administered orally once daily” NCT01780506 ↗ |