Drugs / Elbasvir/grazoprevir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | — | “company’s marketing authorization application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C...” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03420300 | Jun 2018 → Nov 2019 | hepatitis C virus infection | National Taiwan University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2015-12-18 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir merck.com ↗
The CHMP advised Merck that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. |
| 2015-11-15 | Merck Sharp & Dohme LLC | Results Merck to Release Findings from Integrated Analysis of Six Phase 2 and 3 Clinical Trials Evaluating Investigational Elbasvir/Grazoprevir in Patients with Chronic Hepatitis C Genotype 1, 4 or 6 Infection and Compensated Cirrhosis at The Liver Meeting® merck.com ↗
Treatment-experienced patients who received elbasvir/grazoprevir with or without RBV for 16 or 18 weeks achieved virologic cure rates of 100 percent (49/49) and 94 percent (46/49), respectively. |
| 2015-11-15 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 3 Results of Investigational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy merck.com ↗
Ninety-five percent (189/198) of patients treated with elbasvir/grazoprevir for 12 weeks in the pre-specified primary efficacy analysis population achieved sustained virologic response 12 weeks after the completion of treatment (SVR12, considered virologic cure). |
| 2015-10-05 | Merck Sharp & Dohme LLC | Results Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet merck.com ↗
The peer-reviewed, published results show that 12 weeks of therapy with elbasvir plus grazoprevir in patients with chronic HCV GT1 infection and advanced CKD resulted in high rates of sustained virologic response 12 weeks after the completion of treatment (SVR12). |
All press releases naming this drug 5 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elbasvir/grazoprevir | “Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks” NCT03420300 ↗ |
| Known as | EBR/GZR | “Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination \[FDC\]): 1 table per os per day for 12 weeks” NCT03420300 ↗ |
| Route | Oral | “1 table per os per day for 12 weeks” NCT03420300 ↗ |