Drugs / Atripla
Atripla
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 1 milestone | |||||
| Filed | EU (EMA) | Atripla | HIV infectious disease | — | “The marketing authorisation application for ATRIPLA in the European Union was filed” gilead.com ↗ “The MAA for ATRIPLA in the European Union was filed jointly by the three companies” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Atripla | — | 2007-12-13 | europa.eu ↗ |
| Approved | US (FDA) | ATRIPLA | — | 2006-07-12 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01263015 | Feb 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT01095796 | Mar 2010 → Aug 2011 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT03532425 | Oct 2018 → Aug 2020 | HIV infectious disease | University of Alberta | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01778413 | Jun 2013 → Nov 2014 | HIV infectious disease | Anna Cruceta | Completed | No outcome recorded |
| Phase 4 | NCT00615810 | Mar 2008 → Oct 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT00869557 Comparator | Apr → Nov 2009 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02403674 Comparator | Jun 2015 → Mar 2017 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT02283060 Comparator | Sep 2014 → Jul 2016 | HIV infectious disease | University of Hawaii | Unknown | No outcome recorded |
| Phase 4 | NCT02057796 Background | Sep 2014 → Apr 2018 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Missed primary |
| Phase 4 | NCT01815580 Comparator | Jul 2013 → Nov 2020 | HIV infectious disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT01380080 Background | Oct 2011 → Jan 2015 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Missed primary |
| Phase 4 | NCT01343225 Comparator | May 2011 → May 2014 | HIV infectious disease | East Carolina University | Unknown | No outcome recorded |
| Phase 4 | NCT01173510 Comparator | Aug 2010 → Oct 2012 | AIDS | Community Research Initiative of New England | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2018-01-08 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. |
| 2012-03-08 | Gilead Sciences | Results Data Show Gilead’s Quad Regimen for HIV Non-Inferior to Protease-Based Regimen at 48 Weeks in Second Pivotal Phase 3 Study gilead.com ↗
The study found that the Quad was non-inferior to a protease-based regimen of ritonavir-boosted atazanavir (ATV/r) plus Truvada ® (emtricitabine/tenofovir disoproxil fumarate) at 48 weeks of therapy among HIV-1 infected treatment-naïve adults. |
| 2012-03-07 | Gilead Sciences | Results Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗
These data show that the Quad is as effective as a current standard of care in HIV therapy. |
| 2011-12-20 | Gilead Sciences | Regulatory Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Marketing Authorisation Application (MAA) for the Quad single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults, submitted on November 24, 2011 , has been validated by the European Medicines Agency (EMA). |
| 2010-09-13 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase II Study gilead.com ↗
At week 48, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure). |
| 2010-02-17 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" Regimen for HIV Achieves a High Rate of Virologic Suppression in Phase II Study gilead.com ↗
These positive efficacy and safety results indicate that the Quad has the potential to become an important new treatment option in HIV therapy. |
| 2009-10-31 | Gilead Sciences | Results Gilead Announces Long-Term Data from Two Pivotal Phase III Studies Evaluating Viread(R) For Chronic Hepatitis B gilead.com ↗
These new data show that the majority of patients who received Viread for up to 144 weeks experienced sustained suppression of HBV DNA levels in the blood to below 400 copies/mL (87 percent in Study 102 and 71 percent in Study 103). |
| 2009-04-06 | Gilead Sciences | Regulatory Gilead Sciences Announces Notification of ANDA Filing for Atripla(R) gilead.com ↗
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. |
| 2008-11-01 | Gilead Sciences | Results Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread(R) for Chronic Hepatitis B gilead.com ↗
These new data show that patients who received Viread for up to 96 weeks experienced sustained suppression of HBV levels in the blood (91 percent and 78 percent for Studies 102 and 103, respectively). |
| 2007-12-17 | Gilead Sciences | Regulatory European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection gilead.com ↗ |
| 2007-10-18 | Gilead Sciences | Regulatory European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) gilead.com ↗
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. |
| 2007-10-17 | Gilead Sciences | Regulatory Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV gilead.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) announced today that Health Canada has approved ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults. |
| 2007-07-23 | Gilead Sciences | Results 144-Week Data from Gilead's Study 934 Comparing Truvada(R) to Combivir(R) Both in Combination with Sustiva(R) Presented At International AIDS Society Meeting in Sydney gilead.com ↗
today announced the presentation of 144-week data from an ongoing clinical trial, Study 934, comparing a once-daily regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Sustiva(R) (efavirenz) |
| 2006-12-15 | Gilead Sciences | Results 96-Week Data From Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination With Sustiva(R) Published in Journal of Acquired Immune Deficiency Syndrome gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of 96-week data from an ongoing clinical trial, Study 934, in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). |
| 2006-10-09 | Gilead Sciences | Regulatory Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency gilead.com ↗
The MAA for ATRIPLA in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. |
| 2006-08-14 | Gilead Sciences | Results 96-Week Data from Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination with Sustiva(R) Presented at XVI International AIDS Conference gilead.com ↗ |
| 2006-07-12 | Gilead Sciences | Regulatory U.S. Food and Drug Administration (FDA) Approves ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen for Adults with HIV-1 Infection gilead.com ↗ |
All press releases naming this drug 23 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATRIPLA | “Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC)” NCT01263015 ↗13“Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD” NCT00869557 ↗ |
| Known as | efavirenz/emtricitabine/tenofovir disoproxil fumarate | “We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs...” PMID 23392460 ↗ May 2013 |
| Known as | EFV/FTC/TDF | “We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs...” PMID 23392460 ↗ May 20131“Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at...” NCT01380080 ↗ |
| Action | Inhibit | “Atripla contains a non-nucleoside reverse transcriptase (NNRTI) drug efavirenz (EFV)” NCT02283060 ↗ |
| Route | Oral | “once daily for oral administration to be taken on an empty stomach” NCT00615810 ↗ |