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 | “Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014 .” 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 ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-05 | “In November 2014 , Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and 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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01497899 | Dec 2011 → Oct 2012 | AIDS | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2018-08-06 | Gilead Sciences | Regulatory China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Drug Administration (CNDA) has approved Genvoya ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. |
| 2015-11-23 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Genvoya ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. |
| 2015-10-22 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV gilead.com ↗
Genvoya was found to be statistically non-inferior to Stribild ® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF), based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2015-08-20 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment gilead.com ↗
With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles |
| 2015-07-01 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) gilead.com ↗ |
All press releases naming this drug 6 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 NCT01497899 ↗ |
| Route | Oral | “150/150/200/10 mg FDC tablet administered orally once daily” NCT01497899 ↗ |