Drugs / Grazoprevir/Elbasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2015-07-28 | “for review the company’s marketing authorization application (MAA) for grazoprevir/elbasvir for the treatment of adult patients infected with chronic HCV GT 1, 3, 4 or 6.” merck.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-07-28 | “Food and Drug Administration (FDA) has accepted for review the New Drug Application for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT03110055 | May 2017 → May 2018 | hepatocellular carcinoma | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2017-10-21 | Merck Sharp & Dohme LLC | Results Real-World Study Shows ZEPATIER® (Elbasvir and Grazoprevir) Resulted in High Rates of Sustained Virologic Response in Patients with Chronic Hepatitis C Infection Who Have Chronic Kidney Disease merck.com ↗
The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of ZEPATIER. |
| 2017-04-21 | Merck Sharp & Dohme LLC | Results Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C merck.com ↗
For the evaluable population (n=2,436), 95.6 percent of veterans treated with ZEPATIER achieved the primary outcome of sustained virologic response (SVR), defined as undetectable HCV RNA at least twelve weeks after the end of treatment. |
| 2016-11-12 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of New Findings for ZEPATIER™ (Elbasvir and Grazoprevir) in Patients with Chronic Hepatitis C at The Liver Meeting® merck.com ↗
The analysis showed 97 percent of patients (1040/1070) achieved sustained virologic response 12 weeks after the completion of therapy (SVR12, considered virologic cure). |
| 2016-08-08 | Merck Sharp & Dohme LLC | Results Results from Merck’s Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine merck.com ↗
The published efficacy results from the randomized, double-blind, placebo-controlled C-EDGE CO-STAR trial showed 92 percent (184/201) of patients receiving ZEPATIER for 12 weeks in the study’s immediate treatment group achieved SVR12 |
| 2016-05-27 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union merck.com ↗
today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER ™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. |
| 2016-05-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2016 Financial Results merck.com ↗
The FDA approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin. |
| 2016-04-16 | Merck Sharp & Dohme LLC | Results Merck Announces Results From Phase 3 Studies of ZEPATIER™ (Elbasvir and Grazoprevir) in Chronic Hepatitis C Patient Populations at The International Liver Congress™ merck.com ↗
Findings from C-EDGE CO-STAR showed a high rate of SVR 24 weeks after completion of treatment (SVR24) for the baseline chronic HCV infection and provided insights into the incidence of reinfection in this high risk population (abstract #SAT-163). |
| 2016-04-13 | Merck Sharp & Dohme LLC | Results Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial merck.com ↗
In this study, ZEPATIER demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses. |
| 2016-01-28 | Merck Sharp & Dohme LLC | Regulatory Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review merck.com ↗ |
| 2015-07-28 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection merck.com ↗
The FDA granted Priority Review for grazoprevir/elbasvir (100mg/50mg), with a Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016. |
| 2015-07-23 | Merck Sharp & Dohme LLC | Regulatory Merck Announces European Medicines Agency Acceptance of Marketing Authorization Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection merck.com ↗
today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection. |
| 2015-05-28 | Merck Sharp & Dohme LLC | Regulatory Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection merck.com ↗ |
| 2015-04-25 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver CongressTM 2015 merck.com ↗
Following 12 weeks of treatment with a combination of grazoprevir and elbasvir plus RBV, 96 percent of the patients (76/79) with chronic HCV GT1 infection who had failed prior treatment with specified DAA-based regimens achieved SVR12. |
| 2015-04-23 | Merck Sharp & Dohme LLC | Results Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection merck.com ↗
Patients in both the HCV infected, treatment-naïve ( C-EDGE TN ), and HIV/HCV co-infected, treatment-naïve ( C-EDGE CO-INFXN ) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). |
| 2015-04-23 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease merck.com ↗
Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12). |
| 2015-04-08 | Merck Sharp & Dohme LLC | Regulatory Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015 merck.com ↗
grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) |
| 2014-11-11 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients merck.com ↗
The final results were presented in oral sessions at the 65 th American Association for the Study of Liver Diseases (AASLD) Annual Meeting (also known as The Liver Meeting ® ) and published as separate papers online in The Lancet . |
| 2014-11-09 | Merck Sharp & Dohme LLC | Results Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting® merck.com ↗
These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients, |
All press releases naming this drug 23 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 | Grazoprevir/Elbasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03110055 ↗ |
| Known as | ZEPATIER | “Grazoprevir/Elbasvir (ZEPATIER™) and Transarterial Chemoembolization” NCT03110055 ↗ |