Drugs / ombitasvir
ombitasvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Viekirax | — | 2024-09-25 | europa.eu ↗ |
| Approved | EU (EMA) | Viekirax | — | 2015-01-14 | europa.eu ↗ |
| Approved | US (FDA) | VIEKIRA PAK (COPACKAGED) | — | 2014-12-19 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03341988 | Nov 2017 → Jan 2018 | chronic hepatitis C virus infection | Assiut University | Completed | No outcome recorded |
| Phase 1 | NCT02534870 | Sep 2015 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02052362 | Jan → Feb 2014 | — | AbbVie | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04378608 | Jan → Sep 2017 | chronic hepatitis C virus infection | Beni-Suef University | Completed | No outcome recorded |
| Phase 213 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT03067883 | Nov 2016 → Jan 2018 | chronic hepatitis C virus infection | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT02194998 | Sep 2015 → May 2018 | HIV infectious disease, chronic hepatitis C virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02356562 | Feb 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02292719 | Dec 2014 → Jul 2017 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01911845 | Apr → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01782495 | Feb 2013 → Nov 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01609933 | Dec 2012 → May 2017 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01685203 | Aug 2012 → Jun 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01672983 | Jul 2012 → May 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01563536 | Feb → Apr 2012 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 2 | NCT01464827 | Oct 2011 → Mar 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 2 | NCT01458535 | Sep 2011 → May 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 2 | NCT01314261 | Mar 2011 → Jan 2012 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02486406 | Oct 2015 → Nov 2020 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02555943 | Feb 2015 → May 2021 | chronic hepatitis C virus infection, hepatitis B virus infection | Humanity and Health Research Centre | Completed | No outcome recorded |
| Phase 328 trials · 8 met primary · 1 missed | ||||||
| Phase 3 | NCT02806362 | Sep 2016 → Jun 2018 | chronic hepatitis C virus infection | AbbVie | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02634008 | Jun 2016 → Apr 2021 | acute hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 3 | NCT02646111 | Jan 2016 → Jan 2018 | chronic hepatitis C virus infection | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02582632 | Nov 2015 → Aug 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02609659 | Oct 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 3 | NCT02487199 | Sep 2015 → Dec 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02517528 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02504099 | Jul 2015 → Sep 2016 | chronic hepatitis C virus infection | AbbVie | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02517515 | Jul 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02476617 | Jun 2015 → Aug 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442284 | May 2015 → Aug 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02442271 | Apr 2015 → Jul 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02399345 | Mar → Nov 2015 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219477 | Nov 2014 → Jun 2016 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02219490 | Oct 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 3 | NCT02265237 | Oct 2014 → Jul 2016 | hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02207088 | Sep 2014 → Dec 2016 | chronic hepatitis C virus infection, cirrhosis of liver, end stage renal failure | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02216422 | Sep 2014 → Dec 2015 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT02167945 | Jun 2014 → May 2021 | chronic hepatitis C virus infection | AbbVie | Completed | Mixed |
| Phase 3 | NCT02023099 | Dec 2013 → Oct 2014 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01854528 | Jun 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01833533 | Mar → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01854697 | Mar 2013 → Nov 2014 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01767116 | Dec 2012 → Dec 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01715415 | Nov 2012 → Nov 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01716585 | Nov 2012 → Oct 2013 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 3 | NCT01704755 | Oct 2012 → Jan 2014 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01674725 | Aug 2012 → Jan 2014 | chronic hepatitis C virus infection | AbbVie | Completed | Met primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT03499639 | May → Aug 2018 | end stage renal failure, hepatitis C virus infection | Assiut University | Completed | No outcome recorded |
| Phase 4 | NCT03003338 | Oct 2017 → Oct 2018 | chronic hepatitis C virus infection | Hannover Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03050905 | Jun → Nov 2017 | hepatitis C virus infection | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| Phase 4 | NCT02874066 | Mar 2017 → Oct 2018 | viral hepatitis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02950870 | Dec 2016 → Dec 2017 | chronic hepatitis C virus infection | University of Modena and Reggio Emilia | Unknown | No outcome recorded |
| Phase 4 | NCT02498015 | Aug 2016 → Aug 2017 | chronic hepatitis C virus infection | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT03710252 | Mar 2016 → Sep 2017 | chronic hepatitis C virus infection | American Research Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02460133 | Jul 2015 → Oct 2025 overdue | hepatitis C virus infection | Nova Scotia Health Authority | Active not recruiting | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT01181427 Comparator | Aug 2010 → Mar 2011 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1/2 | NCT04391985 Comparator | Mar → Oct 2017 | chronic hepatitis C virus infection | Beni-Suef University | Completed | No outcome recorded |
| Phase 2 | NCT02493855 Background | Jun 2015 → Apr 2016 | chronic hepatitis C virus infection | AbbVie | Completed | Missed primary |
| Phase 2 | NCT01995071 Background | Nov 2013 → Jun 2015 | chronic hepatitis C virus infection, cirrhosis of liver | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02247401 Comparator | Nov 2014 → Aug 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01773070 Background | Jun 2013 → Oct 2016 | hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT03296930 Comparator | Oct 2017 → Sep 2018 | poisoning | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02786537 Comparator | Jun 2016 → Jun 2019 | chronic hepatitis C virus infection | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02734173 Comparator | Jul 2015 → Feb 2017 | hepatitis C virus infection | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02461745 Comparator | Jun 2015 → May 2017 | chronic hepatitis C virus infection | Kaiser Permanente | Completed | No outcome recorded |
| Phase 4 | NCT03133065 Comparator | Sep 2014 → Dec 2016 | — | Ain Shams University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 53
| Date | Issuer | Release |
|---|---|---|
| 2017-02-27 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗
With this positive CHMP opinion, we will bring an eight-week treatment option for the many HCV patients with GT1b. |
| 2016-09-23 | AbbVie | Results AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C abbvie.com ↗
In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR 12 ). |
| 2016-07-25 | AbbVie | Regulatory CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A) abbvie.com ↗ |
| 2016-07-25 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. |
| 2016-04-25 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗ |
| 2016-04-15 | AbbVie | Results AbbVie Announces Real-World Data with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) from Large German Hepatitis C-Registry abbvie.com ↗
These data support results seen in Phase 3 clinical trials for chronic GT1 or GT4 hepatitis C virus (HCV) infected patients treated with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV). |
| 2016-04-14 | AbbVie | Results AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients abbvie.com ↗ |
| 2016-03-30 | AbbVie | Results AbbVie to Present Data on VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) and EXVIERA® (dasabuvir tablets) and Investigational, Pan-Genotypic Regimen at The International Liver Congress™ 2016 abbvie.com ↗
Ombitasvir/Paritaprevir/Ritonavir With Ribavirin Achieves High Sustained Virologic Response (SVR) Rates in Egyptian Adults With Chronic HCV Genotype 4 Infection (AGATE-II) |
| 2016-02-26 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Without Ribavirin for the Treatment of Chronic Hepatitis C in Genotype 1b Patients with Compensated Cirrhosis (Child-Pugh A) in abbvie.com ↗ |
| 2016-01-07 | AbbVie | Regulatory FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis abbvie.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK |
| 2015-12-02 | AbbVie | Regulatory AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection abbvie.com ↗ |
| 2015-11-14 | AbbVie | Results AbbVie Announces New Data on VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Patients with Chronic Hepatitis C Virus Infection With or Without Compensated Cirrhosis abbvie.com ↗
Results show that 95 percent (n=586/615) of patients in the TOPAZ-II trial achieved a sustained virologic response at 12 weeks post-treatment (SVR 12 ) after 12 or 24 weeks of treatment, a secondary endpoint for the study. |
| 2015-10-22 | AbbVie | Regulatory AbbVie Updates U.S. Labels for VIEKIRA PAK® and TECHNIVIE™ abbvie.com ↗
The USPIs for VIEKIRA PAK and TECHNIVIE were updated following post-marketing reports of hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, in patients receiving AbbVie’s HCV treatment, with or without RBV. |
| 2015-09-28 | AbbVie | Regulatory AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval in Japan for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗ |
| 2015-09-11 | AbbVie | Results Ongoing Real World Study Reports High Sustained Viral Response Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Genotype 1 Hepatitis C Patients abbvie.com ↗
This study of Polish patients who reached post-treatment at week 12 (n=40 of 186 enrolled to date), demonstrated 98 percent (n=39/40) SVR 12 . |
| 2015-07-24 | AbbVie | Regulatory TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval as the First and Only All-Oral, Interferon-Free Treatment for Genotype 4 Chronic Hepatitis C in the U.S. abbvie.com ↗
TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. |
| 2015-06-24 | AbbVie | Results AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR 12 ) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. |
| 2015-05-26 | AbbVie | Results AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis abbvie.com ↗
The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR 12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. |
| 2015-04-25 | AbbVie | Results AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX® + EXVIERA® in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress™ 2015 abbvie.com ↗
Patients who reached post-treatment week four to date (n=10 of 20 enrolled) achieved 100 percent SVR 4 (n=10/10). |
| 2015-04-24 | AbbVie | Regulatory U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV). |
| 2015-04-15 | AbbVie | Regulatory AbbVie's Investigational Chronic Hepatitis C Treatment Granted Priority Review in Japan abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. |
| 2015-04-08 | AbbVie | Results AbbVie to Present New Data from Hepatitis C Clinical Development Program at The International Liver Congress™ 2015 abbvie.com ↗
No Significant Interaction Among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir |
| 2015-02-23 | AbbVie | Results Results from AbbVie's Study of VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) Published Online in JAMA; Sub-analyses to be Presented at the Annual Confere abbvie.com ↗
The SVR 12 rates were 91 percent (n=51/56) for subjects with HCV GT1a infection and 100 percent (n=7/7) for those with HCV GT1b infection. |
| 2015-02-11 | AbbVie | Regulatory AbbVie Submits New Drug Application in Japan for its Investigational, All-Oral, Treatment for Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. |
| 2015-01-30 | AbbVie | Results AbbVie Announces Top-line Results from Phase 3 Study of All-Oral Treatment for Hepatitis C in Japan abbvie.com ↗ |
| 2015-01-16 | AbbVie | Regulatory European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX ® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA ® (dasabuvir tablets). |
| 2014-12-19 | AbbVie | Regulatory AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C abbvie.com ↗ |
| 2014-11-21 | AbbVie | Regulatory CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe abbvie.com ↗ |
| 2014-11-11 | AbbVie | Results AbbVie to Present Results from Studies in Chronic Hepatitis C Patients with HIV-1 Co-Infection (TURQUOISE-I) and Liver Transplant Recipients (CORAL-I) at The Liver Meeting® 2014 abbvie.com ↗
AbbVie (NYSE: ABBV) today announced results from studies in chronic hepatitis C patients with human immunodeficiency virus type 1 (HIV-1) co-infection (TURQUOISE-I) and liver transplant recipients (CORAL-I) at The Liver Meeting®2014. |
| 2014-11-11 | AbbVie | Results AbbVie to Present Results from Phase 2 PEARL-I Study in Genotype 4 Chronic Hepatitis C Patients at The Liver Meeting® 2014 abbvie.com ↗
Additionally, 90.9 percent of patients who were new to therapy achieved SVR 12 (n=40/44) after taking the treatment without RBV. |
| 2014-06-17 | AbbVie | Regulatory European Medicines Agency Validates Marketing Authorization Applications for AbbVie's Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. |
| 2014-06-17 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Applications for AbbVie’s Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C enanta.com ↗
Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. |
| 2014-06-13 | AbbVie | Regulatory U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C abbvie.com ↗
has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. |
| 2014-06-13 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C enanta.com ↗
has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. |
| 2014-05-08 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces Submission of EU Marketing Authorization Applications to the European Medicines Agency for All-Oral, Interferon-Free Hepatitis C Regimen Containing ABT-450 enanta.com ↗
AbbVie, Enanta’s collaboration partner for ABT-450, has submitted Marketing Authorization Applications (MAA) to the European Medicines Agency (EMA) seeking approval for its investigational, all-oral, interferon-free regimen for the treatment of adult patients infected with chronic genotype 1 (GT1) hepatitis C virus (HCV). |
| 2014-04-22 | AbbVie | Regulatory AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C abbvie.com ↗
AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. |
| 2014-04-22 | Enanta Pharmaceuticals, Inc | Regulatory Enanta Pharmaceuticals Announces New Drug Application Submission to the U.S. FDA for All-Oral, Interferon-Free Hepatitis C Regimen enanta.com ↗
The U.S. NDA filing triggers a $20 million milestone payment to Enanta from AbbVie. |
| 2014-04-12 | AbbVie | Results AbbVie to Present Late-Breaking Results from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis at the 2014 International Liver Congress™ abbvie.com ↗
Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR 12 ) of 91.8 percent and 95.9 percent in the 12-week and 24-week treatment arms, respectively. |
| 2014-04-12 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis being Presented at the European Association for the Study of the Liver (EASL) Meeting enanta.com ↗
In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic hepatitis C virus, TURQUOISE-II demonstrated SVR12 rates of 91.8% and 95.9% after 12 and 24 weeks of treatment, respectively |
| 2014-04-11 | AbbVie | Results AbbVie to Present Detailed Phase III Results from SAPPHIRE-I and SAPPHIRE-II Studies in Chronic Hepatitis C Patients at the 2014 International Liver Congress™ abbvie.com ↗
These data show very promising results in people who are infected with either subtype of the GT1 hepatitis C virus and who are either new to therapy or treatment-experienced. |
| 2014-04-11 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Detailed Data from SAPPHIRE-I and SAPPHIRE-II Phase 3 Studies in Patients with Chronic Hepatitis C Virus Being Presented at the European Association for the Study of the Liver (EASL) Meeting enanta.com ↗
SVR12 rates of 96% were demonstrated in both treatment-naïve and treatment-experienced genotype 1 (GT1) patients with chronic hepatitis C virus |
| 2014-03-03 | Enanta Pharmaceuticals, Inc | Results PEARL-III Study Results in Patients with Chronic Hepatitis C Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) enanta.com ↗
In the 419-patient study, sustained virologic response rates 12 weeks post-treatment (SVR12) of 99.5 and 99.0 percent were achieved with the three-direct-acting antiviral regimen with and without RBV, respectively. |
| 2014-01-31 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces Results from Four All-Oral, Interferon-Free, Phase 3 Studies for the Treatment of Genotype 1 Hepatitis C Virus Infection enanta.com ↗
Results from these studies demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients and low rates of discontinuation due to adverse events. |
| 2013-12-10 | AbbVie | Results AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of Treatment-Experienced Patients with Genotype 1 Hepatitis C abbvie.com ↗
In the 394-patient SAPPHIRE-II study, 96 percent of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49 percent of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR 12 ) with the regimen. |
| 2013-12-10 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II Study enanta.com ↗
Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. |
| 2013-11-18 | AbbVie | Results AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1 Hepatitis C Patients New to Therapy abbvie.com ↗
In the 631-patient SAPPHIRE-I study, patients new to therapy receiving 12 weeks of AbbVie's 3D regimen achieved a sustained virologic response at 12 weeks post-treatment (SVR 12 ) of 96 percent. |
| 2013-11-18 | Enanta Pharmaceuticals, Inc | Results Enanta Pharmaceuticals Announces 96 Percent SVR12 in SAPPHIRE-I Study enanta.com ↗
Results from the 631 patient SAPPHIRE-I trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in treatment-naïve adult patients chronically infected with GT1 HCV. |
| 2013-11-03 | Enanta Pharmaceuticals, Inc | Results New GT-1b Data from ABT-450 Containing Regimen Being Presented at The Liver Meeting enanta.com ↗
In PEARL-I, SVR12 rates of 95% (40/42) in hepatitis C (HCV) GT-1b treatment-naïve patients and 90% (36/40) among prior null responders will be presented in this intent-to-treat analysis. |
| 2013-10-01 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver Meeting (AASLD) enanta.com ↗
SVR4 rates were 100% (39/39) in GT-1b treatment-naïve patients and 87.9% (29/33) among prior null responders (observed data). |
| 2013-05-06 | AbbVie | Regulatory AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration abbvie.com ↗
AbbVie is pleased that the FDA has granted Breakthrough Therapy designation to our 3-DAA combination with and without ribavirin. |
| 2013-05-06 | Enanta Pharmaceuticals, Inc | Regulatory Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450 enanta.com ↗ |
| 2013-04-23 | AbbVie | Results New Data from AbbVie's Phase IIb Aviator Trial Demonstrate High Sustained Viral Response Rates Across Multiple Patient Types with HCV Genotype 1 abbvie.com ↗
Data show greater than 90 percent SVR were achieved in patients new to treatment and in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). |
| 2013-04-23 | Enanta Pharmaceuticals, Inc | Results Enanta Announces New Data From Phase 2b Interferon-Free Combination Studies with Protease Inhibitor ABT-450 for Hepatitis C Treatment to be Presented at EASL enanta.com ↗
SVR rates of 96% to 99% after 12 weeks of treatment were achieved in patients new to treatment (naïve) and 93% in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). |
All press releases naming this drug 54 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ombitasvir | “Ombitasvir (ABT-267) is a hepatitis C virus (HCV) NS5A inhibitor with picomolar potency, pan-genotypic activity, and 50% effective concentrations (EC50s) of 0.82 to 19.3 pM...” PMID 25451055 ↗ Dec 201447“GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese...” PMID 26147154 ↗ Aug 2015 “The combination of ombitasvir (an NS5A inhibitor), paritaprevir (an NS3/4A inhibitor) coadministered with ritonavir (r), and dasabuvir (an NS5B nonnucleoside polymerase...” PMID 26596948 ↗ Nov 2015 “one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal...” NCT03133065 ↗ “A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With...” NCT03003338 ↗ “Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.” PMID 29909549 ↗ Feb 2019 “12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.” NCT02646111 ↗ “Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients” NCT04391985 ↗ “Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection.” NCT04378608 ↗ “A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection” NCT02498015 ↗ “Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day” NCT02874066 ↗ |
| Known as | ABT-267 | “ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent” NCT02247401 ↗24“Ombitasvir (ABT 267) is an NS5A inhibitor” NCT04378608 ↗ “a NS5a inhibitor (ABT-267; Ombitasvir)” NCT02734173 ↗ “ombitasvir also known as ABT-267” NCT02517515 ↗ |
| Known as | ABT-267 also known as ombitasvir | “ABT-267 also known as ombitasvir” NCT01767116 ↗12“ABT-267 also known as ombitasvir” NCT02219490 ↗ “ABT-267 also known as ombitasvir” NCT01716585 ↗ “ABT-267 also known as ombitasvir” NCT02216422 ↗ “ABT-267 also known as ombitasvir” NCT01674725 ↗ “ABT-267 also known as ombitasvir” NCT01685203 ↗ “ABT-267 also known as ombitasvir” NCT02023099 ↗ “ABT-267 also known as ombitasvir” NCT01715415 ↗ “ABT-267 also known as ombitasvir” NCT01672983 ↗ “ABT-267 also known as ombitasvir” NCT01995071 ↗ “ABT-267 also known as ombitasvir” NCT02219477 ↗ |
| Known as | OBT | “paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)” NCT02194998 ↗ |
| Known as | OBV | “GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese...” PMID 26147154 ↗ Aug 20156“mini-tablet formulations of ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) with or without ribavirin for 12 weeks in children infected with chronic...” PMID 32451952 ↗ May 2020 “Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection.” NCT04378608 ↗ “Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day” NCT02874066 ↗ “Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)” NCT03710252 ↗ “ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r)” PMID 29546644 ↗ Mar 2018 “ombitasvir (OBV; 25mg)” NCT03499639 ↗ |
| Known as | ombitasvir (ABT-267) | “ombitasvir (ABT-267)” NCT02265237 ↗ |
| Known as | ombitasvir also known as ABT-267 | “ombitasvir also known as ABT-267” NCT02399345 ↗6“ombitasvir also known as ABT-267” NCT02582632 ↗ “ombitasvir also known as ABT-267” NCT02442271 ↗ “ombitasvir also known as ABT-267” NCT02504099 ↗ “ombitasvir also known as ABT-267” NCT01782495 ↗ “ombitasvir also known as ABT-267” NCT02207088 ↗ “ombitasvir also known as ABT-267” NCT02442284 ↗ |
| Known as | Ombitasvir component of technivie | ChEMBL registry synonym — accepted as the source's own label CHEMBL3127326 ↗ |
| Known as | Ombitasvir component of viekirax | ChEMBL registry synonym — accepted as the source's own label CHEMBL3127326 ↗ |
| Action | Inhibit | “Ombitasvir (ABT-267) is a hepatitis C virus (HCV) NS5A inhibitor with picomolar potency” PMID 25451055 ↗ Dec 2014 |
| Modality | Small molecule | — CHEMBL3127326 ↗ |
| Route | Oral | “all-oral ombitasvir/paritaprevir/ritonavir and dasabuvir±ribavirin” PMID 26321288 ↗ Aug 2015 |