drugset

Drugs / E/C/F/TAF

Follow last change Jun 2018 re-read 9 days ago

E/C/F/TAF

Developed for: HIV infectious disease
Investigated by: CIHR Canadian HIV Trials Network · Gilead Sciences · Ottawa Hospital Research Institute

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	“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 has submitted New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF, F/TAF and R/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 filed New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF” gilead.com ↗

Trials 1

today NCT02660905 · Ph 3

201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT02660905	Apr 2016 → Jan 2018	HIV infectious disease, chronic hepatitis C virus infection	Ottawa Hospital Research Institute	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 3

Date	Issuer	Release
2016-06-23	Gilead Sciences	Regulatory European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen (STR) Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.
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 ↗
2015-05-28	Gilead Sciences	Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment gilead.com ↗ F/TAF is Gilead’s second F/TAF-based regimen to be validated by the EMA.

All press releases naming this drug 4 releases

Date	Issuer	Release
2016-06-23	Gilead Sciences	European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗
2016-04-29	Gilead Sciences	European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
2015-07-21	Gilead Sciences	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 ↗
2015-05-28	Gilead Sciences	European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment gilead.com ↗

Evidence & citations 1 cited value

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 NCT02660905 ↗