Drugs / Telaprevir
Telaprevir
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 3 milestones | |||||
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2013-01-29 | “Vertex recently submitted a supplemental New Drug Application (sNDA) for a twice-daily dosing regimen of telaprevir to the FDA.” vrtx.com ↗ |
| Filed | Other | — | chronic hepatitis C virus infection | 2013-01-29 | “In January, the company submitted a supplemental New Drug Submission (sNDS) in Canada for a twice-daily dosing regimen of telaprevir.” vrtx.com ↗ |
| Filed | Japan (PMDA) | — | chronic hepatitis C virus infection | 2011-01-26 | “application for the manufacturing and marketing approval of MP-424 (generic name: telaprevir) for treatment of chronic hepatitis C on January 26, 2011.” tanabe-pharma.com ↗ |
| Filed hepatitis C virus infection 3 milestones | |||||
| Filed | Other | — | hepatitis C virus infection | 2011-01-20 | “Vertex completed a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada.” vrtx.com ↗ “completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada” vrtx.com ↗ |
| Filed | EU (EMA) | — | hepatitis C virus infection | 2010-12-17 | “On December 17, 2010, Janssen-Cilag International NV announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for telaprevir” vrtx.com ↗ |
| Filed | US (FDA) | — | hepatitis C virus infection | 2010-11-22 | “announced today that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir” vrtx.com ↗ “On November 22, 2010, Vertex completed the submission of its New Drug Application (NDA) for telaprevir to the United States Food and Drug Administration (FDA).” vrtx.com ↗ “In November 2010, Vertex announced it has completed the submission of a New Drug Application to the U.S. Food and Drug Administration for telaprevir.” vrtx.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Incivo | — | 2016-09-22 | europa.eu ↗ |
| Label expansion | US (FDA) | INCIVEK | — | 2013-10-28 | fda.gov ↗ |
| Approved | EU (EMA) | Incivo | — | 2011-09-19 | europa.eu ↗ |
| Approved | US (FDA) | INCIVEK | — | 2011-05-23 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 68
| Date | Issuer | Release |
|---|---|---|
| 2014-10-10 | Janssen Research & Development, LLC | Results Janssen Demonstrates Continued Commitment to Combating Hepatitis C in European Patients with Data Presented at Viral Hepatitis Congress jnj.com ↗
Overall, simeprevir met its primary endpoint of non-inferiority to telaprevir in treatment-experienced HCV patients and also demonstrated an improved tolerability profile |
| 2013-04-26 | Janssen Research & Development, LLC | Regulatory INCIVO® Receives Positive Opinion From The Committee For Medicinal Products For Human Use (CHMP) For Twice Daily Dosing For Treatment Of Genotype-1 Hepatitis C Virus jnj.com ↗
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. |
| 2013-04-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces New Data that Showed High Viral Cure Rates with a Total of 12 and 24 Weeks of Telaprevir Combination Treatment Among People with Genotype 1 Hepatitis C Who Have the IL28B CC Genotype vrtx.com ↗
In the 12-week total treatment group, of the 85 people with data available at the time of the interim analysis, 87 percent (74/85) had undetectable hepatitis C virus 12 weeks after the end of treatment (SVR12). |
| 2012-12-19 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces Update to U.S. Prescribing Information for INCIVEK® (telaprevir) vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. |
| 2012-11-10 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Phase 3 Data that Showed People with Hepatitis C Treated with Twice-Daily Telaprevir Achieved Viral Cure (SVR12) Rates Similar to Those Treated Three Times Daily vrtx.com ↗ |
| 2012-11-01 | Vertex Pharmaceuticals Incorporated | Results Vertex Reports Third Quarter 2012 Financial Results and Recent Progress in Development Programs vrtx.com ↗
Adverse events were generally similar between both arms of the study and consistent with previous studies. |
| 2012-04-18 | Vertex Pharmaceuticals Incorporated | Results Vertex Advances INCIVEK™ (telaprevir) and Broad Portfolio of Medicines in Development With Goal of Further Expanding and Improving Treatment for People With Hepatitis C vrtx.com ↗
Subanalysis of Phase 2 data shows 12 weeks of INCIVEK combination treatment resulted in a viral cure (SVR) for 100% of people with hepatitis C who had the IL28B CC genotype |
| 2012-03-06 | Vertex Pharmaceuticals Incorporated | Results Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12) vrtx.com ↗ |
| 2012-02-23 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C vrtx.com ↗
Nine of these 11 patients achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment). |
| 2011-11-05 | Vertex Pharmaceuticals Incorporated | Results Positive Interim Data From a Phase 2 Study of INCIVEK™ (telaprevir) Combination Therapy in People Co-Infected with Hepatitis C and HIV Presented at The Liver Meeting® vrtx.com ↗
Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) at Week 24 of treatment compared to 55 percent (12/22) who were treated with pegylated-interferon and ribavirin alone. |
| 2011-11-05 | Vertex Pharmaceuticals Incorporated | Results Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEK™ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR) vrtx.com ↗
Fifty percent (15/30) of patients who received the combination regimen including VX-222 (400mg) were eligible for a total of 12 weeks of treatment and 93 percent (14/15) of them achieved a viral cure (sustained viral response, or SVR). |
| 2011-09-26 | Tanabe Pharma Corporation | Regulatory Approval for TELAVIC® 250mg Tablet Novel Mode of Action for Chronic Hepatitis C Treatment tanabe-pharma.com ↗
Approval for TELAVIC® 250 mg Tablet |
| 2011-09-14 | Vertex Pharmaceuticals Incorporated | Results New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK™ (telaprevir) in Hepatitis C vrtx.com ↗
In this study, 65 percent (352/540) of people had undetectable hepatitis C virus at weeks 4 and 12. |
| 2011-08-22 | Vertex Pharmaceuticals Incorporated | Regulatory Health Canada Approves INCIVEK™ (telaprevir) for People With Hepatitis C vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). |
| 2011-07-26 | Vertex Pharmaceuticals Incorporated | Results Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks vrtx.com ↗
The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. |
| 2011-06-22 | Vertex Pharmaceuticals Incorporated | Results New England Journal of Medicine Publishes Data From Two Phase 3 Studies of INCIVEK™ (telaprevir) in Hepatitis C vrtx.com ↗ |
| 2011-05-23 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). |
| 2011-04-28 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Results Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful vrtx.com ↗
Data from the study showed that people in each of these subgroups who were treated with telaprevir-based combination therapy achieved superior rates of sustained viral response (SVR, or viral cure) compared to those treated with pegylated-interferon and ribavirin alone. |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Results Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C vrtx.com ↗
Among those who received VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin, interim data showed that 90 percent (27/30) of them had undetectable hepatitis C virus at week 12. |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Results Data From Phase 3 Studies Showed Substantial Improvements in SVR (Viral Cure) Rates With Telaprevir-Based Therapy Compared to Currently Available Medicines in People With Hepatitis C, Regardless of Their IL28B Genotype Status vrtx.com ↗ |
| 2011-03-02 | Vertex Pharmaceuticals Incorporated | Results Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference vrtx.com ↗
HIV viral load and CD4 counts were stable among patients receiving a telaprevir-based regimen. |
| 2011-02-03 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Reports 2010 Financial Results and Highlights Recent Progress in Hepatitis C and Cystic Fibrosis Development Programs vrtx.com ↗
Vertex today announced that the European Medicines Agency (EMA) has notified our collaborator Janssen that its telaprevir Marketing Authorisation Application (MAA) was valid and acceptable for review. |
| 2011-01-28 | Tanabe Pharma Corporation | Regulatory Application Submitted in Japan for MP-424 a Novel Chronic Hepatitis C Treatment tanabe-pharma.com ↗
Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the Company submitted an application for the manufacturing and marketing approval of MP-424 (generic name: telaprevir) for treatment of chronic hepatitis C on January 26, 2011. |
| 2011-01-20 | Vertex Pharmaceuticals Incorporated | Regulatory U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. |
| 2010-12-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C vrtx.com ↗
The company has discontinued the second two-drug treatment arm of telaprevir and VX-222 alone as a result of meeting a pre-defined stopping rule related to viral breakthrough. |
| 2010-11-23 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Completes New Drug Application for Telaprevir for Hepatitis C vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C. |
| 2010-10-30 | Vertex Pharmaceuticals Incorporated | Results New Data From Phase 3 Studies Showed Superior SVR (Viral Cure) Rates Achieved with Telaprevir-Based Combination Therapy in People with Hepatitis C, Regardless of Race or Stage of Liver Disease vrtx.com ↗ |
| 2010-10-25 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Third Quarter 2010 Financial Results and Highlights Progress in Hepatitis C and Cystic Fibrosis Development Programs vrtx.com ↗
The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. |
| 2010-09-07 | Vertex Pharmaceuticals Incorporated | Results 65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study vrtx.com ↗ |
| 2010-08-10 | Vertex Pharmaceuticals Incorporated | Results Phase 3 ILLUMINATE Study Supports 24-Week Telaprevir-Based Therapy Within a Response-Guided Regimen for People with Hepatitis C Who Had Not Received Prior Treatment vrtx.com ↗
Sustained viral response (SVR or viral cure) rates of 92% and 88% were observed in the randomized 24 and 48-week telaprevir-based treatment groups, respectively. |
| 2010-05-25 | Vertex Pharmaceuticals Incorporated | Results 75% of Treatment-Naïve Patients with Chronic Hepatitis C Achieve SVR (Viral Cure) with Telaprevir-Based Treatment in Phase 3 Trial vrtx.com ↗
69% of people achieved SVR after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. |
| 2010-04-15 | Vertex Pharmaceuticals Incorporated | Results 59 Percent of Patients Overall Achieved SVR with Telaprevir-Based Regimens in Study 107 After Not Achieving SVR with at Least One Prior Course of Treatment for Hepatitis C Virus Infection vrtx.com ↗ |
| 2010-04-07 | Vertex Pharmaceuticals Incorporated | Results New England Journal of Medicine Publishes PROVE 3 Trial Showing Telaprevir-Based Regimens Significantly Increased Sustained Viral Response (SVR) Rates in Patients Who Did Not Achieve SVR with Prior HCV Therapy vrtx.com ↗
In the trial, 51 percent and 53 percent of patients who received telaprevir in combination with pegylated-interferon and ribavirin as part of a 24-week or 48-week regimen, respectively, achieved SVR. |
| 2009-10-31 | Vertex Pharmaceuticals Incorporated | Results More than 80% of Hepatitis C Patients Treated in Study C208 Achieved an SVR with Telaprevir-Based Regimens vrtx.com ↗
For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen. |
| 2009-10-28 | Vertex Pharmaceuticals Incorporated | Results Interim Results from Study 107 Highlight the Potential Role of Telaprevir-Based Regimens in HCV Patients Who Failed Prior Treatment vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that treatment with telaprevir-based regimens in Study 107 resulted in high sustained viral response (SVR) rates in treatment-failure patients infected with hepatitis C virus (HCV). |
| 2009-09-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Publication of Telaprevir Abstracts for Presentation at the 60th AASLD Meeting vrtx.com ↗
Telaprevir, Peginterferon Alfa-2a and Ribavirin Improved Rates of Sustained Virologic Response (SVR) in "Difficult-to-Cure" Patients With Chronic Hepatitis C (CHC): a Pooled Analysis From the PROVE 1 and PROVE 2 Trials |
| 2009-04-29 | Vertex Pharmaceuticals Incorporated | Results New England Journal of Medicine Publishes Landmark Clinical Studies of the Investigational Hepatitis C Virus Protease Inhibitor Telaprevir vrtx.com ↗
telaprevir dosed in combination with pegylated-interferon (peg-IFN) and ribavirin (RBV) as part of a 24-week treatment regimen resulted in a significant improvement in the rate of sustained viral response (SVR) |
| 2009-04-25 | Vertex Pharmaceuticals Incorporated | Results Telaprevir Data Presented at EASL Show Unprecedented SVR Rates in HCV Treatment-Failure Patients in PROVE 3 Study vrtx.com ↗
Unprecedented sustained viral response (SVR) rates were achieved in hepatitis C-infected treatment-failure patients, including those with cirrhosis, with telaprevir-based treatment according to PROVE 3 trial results presented today in the late breaker session at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. |
| 2009-04-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals to Present Data at EASL Suggesting Telaprevir's Potential for Use in a Broad Range of HCV Patients and Highlighting the Company's Expanded STAT-C Portfolio vrtx.com ↗
Interim data from two Phase 2 studies (C209 and C210) in treatment-naïve HCV patients show substantial antiviral activity against HCV genotypes 2 and 4 when telaprevir is combined with the standard of care compared with standard of care alone. |
| 2008-11-01 | Vertex Pharmaceuticals Incorporated | Results New Clinical Data Support Broad Profile for Telaprevir in Patients with Genotype 1 Hepatitis C Virus (HCV) Infection vrtx.com ↗
The PROVE 3 data show a 52% SVR12 in HCV treatment-failure patients, with a 24-week treatment duration. |
| 2008-09-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Correction to Abstract Data Published in October 2008 Supplement to Hepatology vrtx.com ↗
The correctly labeled table, and the corresponding HCV RNA results, are provided below: |
| 2008-06-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment vrtx.com ↗ |
| 2008-04-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Interim Results with Telaprevir-based Therapy in Genotype 1 Chronic Hepatitis C Patients who Failed to Achieve SVR with Previous Pegylated Interferon & Ribavirin Treatment vrtx.com ↗
In the interim analysis, patients treated with telaprevir in combination with peg-IFN and RBV demonstrated a high rate of viral response at week 4 (49 of 60 patients achieved HCV RNA 25 IU/mL). |
| 2008-04-23 | Vertex Pharmaceuticals Incorporated | Results Telaprevir-Based PROVE Studies Show Significantly Higher SVR Rates in Treatment-Naive Genotype 1 Hepatitis C Patients in Half the Time of Current Treatments vrtx.com ↗ |
| 2007-11-02 | Vertex Pharmaceuticals Incorporated | Results First Studies Demonstrating Greater than Sixty Percent Sustained Viral Response Rates with Half the Standard Treatment Duration in Genotype 1 Chronic Hepatitis C Patients vrtx.com ↗
In 24-week telaprevir-based treatment regimens, genotype 1 treatment-naive HCV patients achieved sustained viral response rates of 61% and 65% in PROVE 1 (SVR 12 and SVR 24) and PROVE 2 (SVR 12), respectively. |
| 2007-07-24 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Second Quarter 2007 Financial Results and Provides Development Pipeline Update vrtx.com ↗
Among the patients who completed 24 weeks of therapy and had undetectable HCV RNA (less than 10 IU/mL) at the end of treatment, fewer than 10 percent had relapsed by the end of 12 weeks post-treatment follow-up. |
| 2007-06-12 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports 2007 Pipeline Progress vrtx.com ↗
At this time, Vertex is reporting that the preliminary results are consistent with findings reported for PROVE 1. |
| 2007-04-14 | Vertex Pharmaceuticals Incorporated | Results Interim Results Presented at EASL from PROVE 1 Clinical Trial of Investigational Drug Telaprevir in Patients with Genotype 1 Hepatitis C vrtx.com ↗
Treatment with telaprevir resulted in a high proportion of patients achieving a rapid viral response at 4 weeks. |
| 2006-12-13 | Vertex Pharmaceuticals Incorporated | Results Pharmaceuticals Announces Results of First Interim Safety and Antiviral Analysis of the PROVE 1 Clinical Trial of Investigational HCV Protease Inhibitor Telaprevir (VX-950) vrtx.com ↗
At week 12, 65 of the 74 patients (88%) for whom data was available in the telaprevir groups demonstrated undetectable HCV RNA (less than 10 IU/mL; Roche Taqman). |
| 2006-10-27 | Vertex Pharmaceuticals Incorporated | Results New Data for Investigational Hepatitis C Drug Telaprevir (VX-950) to be Presented at AASLD Meeting vrtx.com ↗
Clinical investigators will also report that some of these patients have stopped therapy, and that a proportion of them continued to have undetectable HCV RNA after stopping therapy. |
| 2006-05-21 | Vertex Pharmaceuticals Incorporated | Results Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients vrtx.com ↗
No viral breakthrough was observed in any patient during 28 days of VX-950 dosing. |
| 2006-04-29 | Vertex Pharmaceuticals Incorporated | Results Researchers Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C Patients vrtx.com ↗
Researchers reported for the first time today that 8 of 8 patients who received VX-950 and peg-IFN in combination for 14 days have no detectable virus in their blood at the end of 12 additional weeks of peg-IFN+RBV dosing. |
| 2006-04-26 | Vertex Pharmaceuticals Incorporated | Results New Data Highlight Anti-HCV Activity of Investigational Oral Hepatitis C Protease Inhibitor VX-950 vrtx.com ↗
In a second presentation, researchers will describe results of a whole genome analysis that suggests that the expression level of interferon-sensitive genes may be restored with VX-950 treatment. |
| 2006-02-07 | Vertex Pharmaceuticals Incorporated | Results Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program vrtx.com ↗
Plasma HCV RNA levels are less than 10 IU/mL in 12 of 12 patients after 28 days of dosing with VX-950/peg-IFN/RBV in Phase II study |
| 2006-02-06 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports 2005 Financial Results vrtx.com ↗
In the study, 12 of 12 patients had plasma HCV RNA levels below the limits of detection of a highly sensitive assay (10 IU/mL; Roche TaqMan®) at 28 days of dosing. |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon vrtx.com ↗
The antiviral activity of the combination through 14 days was significantly greater than the activity of VX-950 administered as a single agent, and much greater than peg-IFN alone. |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Key Business Objectives for 2006 at 24th Annual JPMorgan Healthcare Conference vrtx.com ↗
In this study, patients receiving a combination of VX-950 dosed with peg-IFN achieved a median 5.5 log10 reduction in HCV RNA at 14 days. |
| 2006-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Announces Key Business Objectives for 2006 at 24th Annual JPMorgan Healthcare Conference vrtx.com ↗
In this study, patients receiving a combination of VX-950 dosed with peg-IFN achieved a median 5.5 log10 reduction in HCV RNA at 14 days. |
| 2005-12-08 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection. |
| 2005-12-08 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950 vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection. |
| 2005-11-11 | Vertex Pharmaceuticals Incorporated | Results AASLD Presentations Support the Initiation of a Broad Phase II Program with VX-950, an Investigational Oral HCV Protease Inhibitor vrtx.com ↗
Clinical data being presented this week while attending the 56th American Association for the Study of Liver Diseases (AASLD) Annual Meeting confirm that VX-950, an investigational oral hepatitis C protease inhibitor developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), was well-tolerated and possessed potent antiviral activity in a 14-day study in patients with hepatitis C virus (HCV) infection. |
| 2005-10-03 | Vertex Pharmaceuticals Incorporated | Results New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track vrtx.com ↗
Data from a 14-day clinical study demonstrated that treatment with any one of three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in all dose groups. |
| 2005-05-17 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports that Oral Hepatitis C Protease Inhibitor, VX-950, Dramatically Reduces Viral Levels in Phase Ib Clinical Study vrtx.com ↗
In addition, patients treated with 750 mg of VX-950 every eight hours achieved a median reduction of HCV-RNA of 4.4 log10, equivalent to a 25,000-fold reduction in viral levels, at the end of 14 days of treatment. |
| 2005-05-10 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports that VX-950, an Investigational Oral Hepatitis C Protease Inhibitor, Displays Potent Antiviral Activity in Early Clinical Study vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results that indicate that the investigational oral hepatitis C virus (HCV) protease inhibitor VX-950 was well-tolerated and demonstrated potent antiviral activity in a Phase Ib clinical trial. |
| 2004-11-01 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Positive Results from First-in-Human Study for VX-950, an Investigational Oral Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗
In the study, VX-950 was well-tolerated at all dose levels and was not associated with any serious adverse events. |
| 2004-09-07 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Completion of Dosing in the Phase Ia Clinical Study of VX-950, an Oral HCV Protease Inhibitor for the Treatment of Hepatitis C vrtx.com ↗
No dose-limiting toxicities were identified, and a maximum tolerated dose was not reached. |
| 2004-05-04 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Data Suggesting Potential for Oral Combination Approaches in Treatment of HCV vrtx.com ↗
All combinations of merimepodib (MMPD) and VX-950 resulted in greater reduction of HCV RNA than either agent alone, and computational analysis determined that the antiviral effects of MMPD and VX-950 were additive to moderately synergistic. |
All press releases naming this drug 102 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 102 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Telaprevir | “Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the...” NCT01743521 ↗75“Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised,...” PMID 25482330 ↗ Dec 2014 “A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection” NCT01241760 ↗ “Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection” NCT01253551 ↗ “telaprevir (TVR) is given as oral tablets” NCT01582035 ↗ “MP-424 (generic name:Telaprevir)” NCT01468584 ↗ “MP-424 (Telaprevir)” NCT00591214 ↗ |
| Known as | Incivek | “This study is for people who have been diagnosed with chronic hepatitis C, specifically those who have a certain type of the virus, genotype 1, and who have not yet received...” NCT01890772 ↗1“telaprevir 750 mg tid (Incivek®)” NCT01592006 ↗ |
| Known as | Incivek (telaprevir) | “Incivek (telaprevir)” NCT01532908 ↗ |
| Known as | Incivo | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | LY 570310 | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | MP-424 | “MP-424 (generic name:Telaprevir)” NCT01466192 ↗ |
| Known as | TPV | “Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the...” NCT01743521 ↗2“Telaprevir plus pegylated interferon/ribavirin (TPV+PegIFN/RBV)” PMID 26321288 ↗ Aug 2015 “ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV)” NCT02006745 ↗ |
| Known as | TVR | “This study aimed to characterize the pharmacokinetic parameters of telaprevir (TVR) in patients with moderate and severe hepatic impairment, measure the unbound...” PMID 25975934 ↗ Jul 201510“We evaluated the association between baseline HOMA-IR and pretreatment factors on sustained virologic response (SVR) to telaprevir (TVR) in genotype 1 patients with hepatitis C...” PMID 24382638 ↗ Oct 2013 “The purpose of this study is to investigate the effect of steady-state telaprevir (TVR 750 mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of...” NCT00933894 ↗ “750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from...” NCT01336829 ↗ “Telaprevir (TVR) plus peginterferon-α2a (PEG-IFN-α2a) and ribavirin substantially increases treatment efficacy for genotype 1 chronic hepatitis C virus (HCV) infection versus...” PMID 23685940 ↗ Jul 2013 “We studied 15 patients chronically infected with genotype 1 HCV treated with telaprevir (TVR)/pegylated-interferon alpha/ribavirin.” PMID 24811404 ↗ Jul 2014 “All participants will receive a single 750-mg dose of telaprevir (TVR) given by mouth as 2 tablets of 375 mg.” NCT00903773 ↗ “Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy” NCT01718145 ↗ “TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use.” NCT01485991 ↗ “TVR (Telaprevir)” NCT00828789 ↗ |
| Known as | VRT 111950 | ChEMBL registry synonym — accepted as the source's own label CHEMBL231813 ↗ |
| Known as | VX-950 | “A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection” NCT00580801 ↗4“Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours” NCT00528528 ↗ “telaprevir (VX-950)” NCT00509210 ↗ |
| Action | Inhibit | “Telaprevir, a protease inhibitor specific to the HCV nonstructural 3/4A serine protease, rapidly reduced HCV RNA levels in early studies.” PMID 19403902 ↗ Apr 2009 |
| Modality | Small molecule | “an orally available small molecule inhibitor of the HCV-1 protease” NCT01415141 ↗ |
| Route | Oral | “Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks” NCT00336479 ↗ |