Drugs / EVG/COBI/FTC/TDF
EVG/COBI/FTC/TDF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Stribild | HIV infectious disease | 2011-12-20 | “A Marketing Authorisation Application (MAA) for the regimen was validated for review by the European Medicines Agency (EMA) on December 20, 2011 .” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT01721109 | Dec 2012 → Oct 2015 | AIDS | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| 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. |
| 2017-02-14 | Gilead Sciences | Results Gilead Announces 144-Week Data Evaluating Safety and Efficacy of Genvoya® for Treatment of HIV-1 in Treatment-Naïve Adults gilead.com ↗
Through Week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild ® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 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 ↗
Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU). |
| 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 ↗ |
| 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 ↗ |
| 2015-04-07 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for two doses of an 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 in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents. |
| 2013-10-16 | Gilead Sciences | Results Gilead’s Single Tablet HIV Regimen Stribild® Demonstrates Durable Viral Suppression Through Three Years of Therapy gilead.com ↗ |
| 2013-09-12 | Gilead Sciences | Results Gilead’s Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase 2 Study gilead.com ↗
In this study, the TAF-based regimen matched Stribild’s high viral suppression and demonstrated a favorable safety profile with respect to renal and bone changes. |
| 2013-05-28 | Gilead Sciences | Regulatory European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
This approval allows for the marketing of Stribild in all 27 countries of the European Union . |
| 2013-03-22 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Stribild®, a Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
FOSTER CITY, Calif. --(BUSINESS WIRE)--Mar. 22, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild ® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. |
| 2013-03-05 | Gilead Sciences | Results Gilead Announces Full 24-Week Phase 2 Results for Once-Daily Single Tablet HIV Regimen Containing Novel Prodrug Tenofovir Alafenamide (TAF) gilead.com ↗
A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Once-Daily Single Tablet Regimen Stribild™ Maintains High Viral Suppression Through Two Years of Therapy Among Treatment-Naïve HIV Patients gilead.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EVG/COBI/FTC/TDF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01721109 ↗ |
| Known as | Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate | “A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet...” NCT01721109 ↗ |
| Known as | Stribild | “Stribild®” NCT01721109 ↗ |
| Route | Oral | “administered orally” NCT01721109 ↗ |