Drugs / Simeprevir
Simeprevir
also known as
TMC435 · SMV · TMC435350 · jnj-38733214-aaa · Olysio is a trade name of simeprevir · F021 · G006 · G007 · +3 more
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 5 milestones | |||||
| Filed | US (FDA) | OLYSIO | chronic hepatitis C virus infection | 2015-07-23 | “Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir” jnj.com ↗ |
| Filed | US (FDA) | OLYSIO | chronic hepatitis C virus infection | 2014-05-07 | “a supplemental New Drug Application (sNDA) was submitted to the FDA seeking approval for simeprevir in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir” jnj.com ↗ “Janssen has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Association (FDA) for simeprevir” medivir.com ↗ “A supplemental New Drug Application for simeprevir in combination with sofosbuvir was submitted to the US FDA.” medivir.com ↗ “Janssen recently submitted a new drug application for simeprevir in Japan and the United States.” medivir.com ↗ “Janssen recently submitted new drug applications in Japan and the United States for simeprevir” medivir.com ↗ “Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir)” jnj.com ↗ |
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2013-04-24 | “Janssen Submits Marketing Authorisation Application for Simeprevir (TMC435) to the European Medicines Agency for the Treatment of Adult Patients with Chronic Hepatitis C” jnj.com ↗ “today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435)” medivir.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2013-03-28 | “Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C” jnj.com ↗ |
| Filed | Japan (PMDA) | — | chronic hepatitis C virus infection | 2013-02-22 | “Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir” medivir.com ↗ “Janssen Files First Regulatory Application for Simeprevir (TMC435) for the Treatment of Genotype 1 Hepatitis C Patients in Japan” jnj.com ↗ “Janssen Pharmaceutical K.K. recently announced the submission of a new drug application for simeprevir in Japan” medivir.com ↗ “Janssen recently submitted a new drug application for simeprevir in Japan and the United States.” medivir.com ↗ “Janssen recently submitted new drug applications in Japan and the United States for simeprevir” medivir.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Olysio | — | 2018-05-01 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | OLYSIO | — | 2014-11-05 – 2016-05-20 | fda.gov ↗ |
| Approved | EU (EMA) | Olysio | — | 2014-05-14 | europa.eu ↗ |
| Approved | US (FDA) | OLYSIO | — | 2013-11-22 | fda.gov ↗ |
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EU approved 2014
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News releases announcing trial results or a regulatory action · 63
| Date | Issuer | Release |
|---|---|---|
| 2017-10-23 | Medivir | Results Data on the clinical activity of simeprevir in combination with AL-335 and odalasvir (JNJ-4178) presented at the 2017 Liver Meeting™ medivir.com ↗
The triple combination was generally well-tolerated in both arms of the study, with the most frequent adverse events being headache and fatigue. |
| 2017-04-24 | Medivir | Results Update on the development of simeprevir as part of the triple combination with AL-335 and odalasvir (JNJ-4178) medivir.com ↗
The three-drug regimen achieved 100% SVR12 for 6- and 8-week treatment duration in treatment-naïve, GT1, non-cirrhotic patients. |
| 2016-09-23 | Medivir | Results Updated interim phase IIa data demonstrate that the combination of simeprevir, odalasvir and AL-335 has a high level of efficacy in HCV patients medivir.com ↗ |
| 2015-11-16 | Janssen Research & Development, LLC | Results Janssen Presents New Data Assessing OLYSIO® (Simeprevir) in Combination with Sofosbuvir in Genotype 4 Infected HCV Patients In Egypt jnj.com ↗ |
| 2015-07-24 | Medivir | Regulatory Medivir announces that Janssen submitted supplemental New Drug Application to U.S. FDA for OLYSIO® (simeprevir) in combination with sofosbuvir medivir.com ↗
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR ) today announces that Janssen Products, LP (Janssen ), has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). |
| 2015-07-23 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir jnj.com ↗
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). |
| 2015-04-23 | Medivir | Results Data from OPTIMIST trials show SVR12 rates of 97 percent in HCV patients without cirrhosis and 84 percent in HCV patients with cirrhosis medivir.com ↗
Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control. |
| 2015-04-23 | Janssen Research & Development, LLC | Results Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir ▼ Plus Sofosbuvir ▼ in Genotype 1 HCV Patients With and Without Cirrhosis jnj.com ↗ |
| 2015-04-08 | Janssen Research & Development, LLC | Results Janssen Highlights Hepatitis C Virus Development Program at The International Liver Congress® 2015 of the European Association for the Study of the Liver (EASL) jnj.com ↗ |
| 2015-03-16 | Medivir | Results New data on Simeprevir presented at the Conference of the Asian Pacific Association for the Study of the Liver medivir.com ↗
In a phase II study up to 95% cure rates were achieved in HCV genotype (GT)1 infected patients treated with a 3-DAA combination of simeprevir, TMC647055/ritonavir and JNJ-56914845. |
| 2014-11-06 | Medivir | Regulatory Olysio® gains additional FDA approval as all-oral treatment in combination with sofosbuvir for treatment of hepatitis C infection medivir.com ↗ |
| 2014-11-05 | Janssen Research & Development, LLC | Regulatory OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection jnj.com ↗
OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection |
| 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 |
| 2014-07-28 | Medivir | Results Phase II COSMOS study results published in The Lancet on World Hepatitis Day medivir.com ↗
According to results from the study, the all-oral, interferon-free treatment regimen with simeprevir and sofosbuvir resulted in consistent SVR12 rates regardless of degree of fibrosis, and was an effective and well-tolerated therapeutic regimen in both treatment-naïve and prior null-responder patients. |
| 2014-07-28 | Janssen Research & Development, LLC | Results Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen's Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C jnj.com ↗
Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen's Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C |
| 2014-07-15 | Medivir | Regulatory U.S. FDA has granted Priority Review for OLYSIO® in combination with sofosbuvir supplementary New Drug Application medivir.com ↗
Medivir AB (OMX: MVIR) announces that the Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C. |
| 2014-05-16 | Medivir | Regulatory Simeprevir approved in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection medivir.com ↗
Medivir AB (OMX: MVIR) today announces that simeprevir has been granted marketing authorisation by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic hepatitis C in combination with other medicinal products. |
| 2014-05-16 | Janssen Research & Development, LLC | Regulatory OLYSIO™ (simeprevir) receives marketing authorisation in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection jnj.com ↗
OLYSIO™ (simeprevir) receives marketing authorisation in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection |
| 2014-05-07 | Medivir | Regulatory A supplemental New Drug Application has been submitted to the U.S. FDA for Simeprevir in combination with Sofosbuvir medivir.com ↗
The filing includes data from treatment naïve patients with advanced liver fibrosis and prior null responders with all stages of liver fibrosis. |
| 2014-05-07 | Janssen Research & Development, LLC | Regulatory Study Found INVEGA® SUSTENNA® (paliperidone palmitate) Once-Monthly Long-Acting Therapy Delayed Time to and Reduced Risk of Relapse in Individuals with Schizoaffective Disorder as Monotherapy and Adjunctive Therapy jnj.com ↗
Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once -Daily Use in Combination with Sofosbuvir |
| 2014-04-12 | Janssen Research & Development, LLC | Results Final Data from the Phase 2 COSMOS Study of Janssen's Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL) jnj.com ↗
Final results from cohort 2 of the Phase 2 COSMOS study demonstrated that 93 percent of patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). |
| 2014-03-24 | Janssen Research & Development, LLC | Regulatory Janssen receives positive CHMP opinion for simeprevir in the treatment of adults with chronic hepatitis C in the European Union jnj.com ↗
Janssen receives positive CHMP opinion for simeprevir in the treatment of adults with chronic hepatitis C in the European Union |
| 2014-01-13 | Medivir | Results Interim results (SVR4) from a phase II all-oral combination study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C medivir.com ↗
85 percent (n=17/20) of the patients achieved SVR4 (undetectable HCV RNA four weeks after end of treatment). |
| 2013-11-22 | Janssen Research & Development, LLC | Regulatory OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C jnj.com ↗
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced today the U.S. Food and Drug Administration (FDA) has approved OLYSIO TM (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. |
| 2013-11-04 | Medivir | Results Results from the COSMOS study with Simeprevir and Sofosbuvir in cirrhotic and non-cirrhotic HCV genotype 1 patients presented at AASLD medivir.com ↗
The high sustained virologic response (SVR) rates seen in genotype 1 patients with prior null response and in treatment-naïve and prior null response patients with advanced liver disease, in the COSMOS study, are highly encouraging. |
| 2013-11-02 | Medivir | Results Medivir announces that new Simeprevir data will be presented at the AASLD meeting medivir.com ↗
In the analyses of the QUEST-1 and QUEST-2 phase III studies in treatment-naïve patients and the phase III PROMISE study in prior relapse patients, efficacy of simeprevir was demonstrated in hepatitis C patients, including patients with the IL28B TT genotype and METAVIR scores of F4 (cirrhosis). |
| 2013-10-24 | Medivir | Regulatory FDA Advisory Committee recommends approval of Simeprevir for combination treatment of genotype 1 chronic hepatitis C in adult patients medivir.com ↗
The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-naïve or who have failed previous interferon-based therapy. |
| 2013-10-24 | Janssen Research & Development, LLC | Regulatory FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients jnj.com ↗
Janssen Research & Development, LLC (Janssen) announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously (19 to 0) to recommend approval of the investigational protease inhibitor simeprevir (TMC435) administered once daily as a 150 mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. |
| 2013-09-27 | Janssen Research & Development, LLC | Regulatory Japanese Health Authority Approves SOVRIAD™ for the Treatment of Genotype-1 Chronic HCV Infection jnj.com ↗
Janssen Pharmaceutical K.K. (Headquarters: Chiyoda -ku, Tokyo, President: Bruce Goodwin; henceforth "Janssen") announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SOVRIAD™ (simeprevir sodium) for the treatment of genotype -1 chronic hepatitis C virus (HCV) infection.* |
| 2013-06-06 | Medivir | Results Primary efficacy and safety data from four phase III Japanese studies of Simeprevir presented at The Japan Society of Hepatology medivir.com ↗
The data were presented today at The Japan Society of Hepatology’s 49th Annual Meeting in Tokyo. |
| 2013-06-06 | Janssen Research & Development, LLC | Results Primary Efficacy and Safety Findings from Four Phase 3 Japanese Studies of Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Adult Patients jnj.com ↗
Eighty -nine percent of patients in the simeprevir arm achieved SVR12 compared to 62 percent in the placebo arm. |
| 2013-05-21 | Medivir | Results Primary efficacy and safety findings from phase III study of Simeprevir in treatment-experienced patients demonstrate sustained virologic response medivir.com ↗
Results demonstrated that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79 percent of treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis. |
| 2013-05-21 | Janssen Research & Development, LLC | Results Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients jnj.com ↗
In the simeprevir arm, on-treatment failure rates were 3 percent and relapse rates were 19 percent, compared to 27 percent and 48 percent in the placebo arm. |
| 2013-05-13 | Medivir | Regulatory U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C medivir.com ↗
the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435) |
| 2013-05-13 | Janssen Research & Development, LLC | Regulatory U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C jnj.com ↗
U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C |
| 2013-04-24 | Medivir | Regulatory Marketing Authorization Application for Simeprevir to the EMA for the treatment of patients with genotype 1 and genotype 4 hepatitis C is now filed medivir.com ↗
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that Janssen-Cilag International NV (Janssen) today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435). |
| 2013-04-24 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Simeprevir (TMC435) to the European Medicines Agency for the Treatment of Adult Patients with Chronic Hepatitis C Genotype 1 or Genotype 4 jnj.com ↗
Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application to the European Medicines Agency seeking approval for simeprevir (TMC435). |
| 2013-04-23 | Medivir | Results New data from Simeprevir phase III studies Quest 1 and 2 in hepatitis C patients will be presented at EASL 23-28 April in Amsterdam medivir.com ↗
These primary efficacy and safety results from two global phase III studies demonstrate that use of the investigational protease inhibitor simeprevir led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naïve genotype 1 chronic hepatitis C adult patients with compensated liver disease, when administered once daily with pegylated interferon and ribavirin. |
| 2013-04-23 | Janssen Research & Development, LLC | Results Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients jnj.com ↗
Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients |
| 2013-03-28 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C jnj.com ↗
Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C |
| 2013-03-06 | Medivir | Results Results from a phase IIa study evaluating Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients have been presented at CROI medivir.com ↗
In an all-oral regimen of simeprevir and sofosbuvir 96.3 percent (26/27) and 92.9 percent (13/14) of patients in the 12-week arm with ribavirin and without ribavirin achieved sustained virologic response 8 weeks after the end of treatment (SVR8). |
| 2013-03-04 | Medivir | Results First interim results from a phase IIa study evaluating an all-oral regimen of Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients medivir.com ↗
The regimen of once-daily simeprevir and sofosbuvir with or without ribavirin was generally well tolerated and no serious adverse events occurred during the treatment period for the patients involved in the study. |
| 2013-02-22 | Medivir | Regulatory Regulatory Application has now been filed for Simeprevir (TMC435) in Japan for the treatment of genotype 1 hepatitis C patients medivir.com ↗
Medivir AB (OMX: MVIR) today announced that its partner Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV. |
| 2013-02-22 | Janssen Research & Development, LLC | Regulatory Janssen Files First Regulatory Application for Simeprevir (TMC435) for the Treatment of Genotype 1 Hepatitis C Patients in Japan jnj.com ↗
Janssen Pharmaceutical K.K. (Janssen) today announced it has submitted a regulatory application to Japanese health authorities seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, as well as patients who were non -responders to prior therapy or relapsed following treatment with pegylated interferon with or without ribavirin. |
| 2012-12-20 | Medivir | Results Medivir announces phase III data for Simeprevir demonstrating efficacy and safety in genotype 1 hepatitis C patients medivir.com ↗
Simeprevir achieved SVR12 rates (viral cure) of 79% to 81% in the three pivotal phase III trials QUEST-1, QUEST-2 and PROMISE in genotype 1 hepatitis C patients. |
| 2011-11-15 | Medivir | Results Key news from the ongoing Capital Markets Day medivir.com ↗
In the 150 mg TMC435 treatment groups, 81-86 percent of patients achieved SVR24, compared to 65 percent of patients treated in the placebo arm. |
| 2011-11-07 | Medivir | Results Medivir’s partner Tibotec announced that final SVR24 results from phase IIb PILLAR study of TMC435 will be presented at the AASLD meeting today medivir.com ↗
Results from the final PILLAR analysis showed that TMC435 administered in combination with peginterferon α-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR. |
| 2011-11-02 | Medivir | Results Medivir Announces Final Results from TMC435 Phase IIb ASPIRE (C206) Study medivir.com ↗
Data from the ASPIRE study showed that patients in each of these subgroups who were treated with TMC435-based combination therapy achieved superior rates of sustained virologic response (viral cure) compared with those retreated with PegIFN and RBV alone. |
| 2011-09-30 | Medivir | Results Medivir Announces Acceptance of Four TMC435 Abstracts for Presentation at the AASLD Meeting medivir.com ↗
Significantly higher response rates were observed with TMC435 compared to control. |
| 2011-07-06 | Medivir | Regulatory TMC435 has Received Fast Track Designation from the FDA and TMC435 will be studied in combination withPharmasset's PSI-7977 for HCV genotype-1 medivir.com ↗
Medivir today announced that its investigational protease inhibitor TMC435 has received “Fast Track” designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of chronic hepatitis C (CHC) genotype-1 infection. |
| 2011-05-20 | Medivir | Results Medivir Announces Positive 48-week Interim Data from TMC435 Hepatitis C Phase 2b ASPIRE Study in Treatment-Experienced Genotype-1 Patients medivir.com ↗
All TMC435 patient subgroups achieved substantially higher SVR4 rates (undetectable virus 4 weeks after end of treatment) compared to pegylated-interferon and ribavirin alone |
| 2011-04-01 | Medivir | Results Medivir: Week 24 Interim Results from TMC435 Hepatitis C Phase 2b ASPIRE Study presented at EASL medivir.com ↗
In this Week 24 interim analysis, treatment-experienced patients who failed peginterferon and ribavarin treatment achieved significantly greater virologic response rates following treatment with TMC435-containing regimen at all doses, compared with placebo. |
| 2011-02-22 | Medivir | Results Medivir Announces positive Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-naïve Patients medivir.com ↗
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naïve patients with hepatitis C virus (HCV) genotype-1. |
| 2011-02-22 | Medivir | Results Financial Statement, 1 January – 31 December 2010 medivir.com ↗
As of today, Medivir reported positive 48-week interim data (SVR24) from the PILLAR trial (C205), a phase 2b trial on TMC435 on treatment-naive patients. |
| 2010-11-18 | Medivir | Results Medivir Announces Positive 24-week Interim Data of TMC435 from the ASPIRE Study (C206) medivir.com ↗
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases announces today positive top-line 24-week interim data from the Phase 2b ASPIRE (C206) study of TMC435 in treatment-experienced hepatitis C patients. |
| 2010-11-01 | Medivir | Results Medivir Notes that Partner Tibotec Announced Week 24 Interim Results from Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at AASLD medivir.com ↗
79% to 86% of patients were able to stop all therapy at week-24 |
| 2010-07-12 | Medivir | Results Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus medivir.com ↗
Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205). |
| 2009-11-04 | Medivir | Results New Phase IIa data on TMC435 in patients with hepatitis C presented at the ongoing AASLD - meeting medivir.com ↗
Each of the four patients who completed treatment with TMC435 achieved HCV RNA levels below the lower limit of quantification (25 IU/mL) at Day 28 with three out of four patients having HCV RNA levels below the lower limit of detection (10 IU/mL). |
| 2009-04-24 | Medivir | Results New Phase IIa data on TMC435 in patients with hepatitis C presented at the ongoing EASL - meeting medivir.com ↗
Data were presented from the phase IIa trial (OPERA-1) for TMC435 at the ongoing 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark, April 22-26. |
| 2008-09-24 | Medivir | Results Phase IIa data on TMC435350 in patients with hepatitis C to be presented at AASLD medivir.com ↗
“These data demonstrate the potent antiviral activity of TMC435350 against genotype-1 HCV” |
| 2008-04-24 | Medivir | Results First data on TMC435350 in patients with hepatitis C who have failed previous treatment shows antiviral activity medivir.com ↗
Five days dosing with 200 mg TMC435350 dosed once-daily resulted in a median reduction of viral load of 3.9 log10 units/mL on day 6. |
| 2007-10-01 | Medivir | Results Phase Ia data on TMC435350 to be presented at AASLD medivir.com ↗
Data from the phase Ia clinical trial show that TMC435350 was well tolerated in single doses up to 600 mg and in 5 days of dosing up to 400 mg once-daily. |
| 2007-09-10 | Medivir | Results Preclinical data presented on new Hepatitis C protease inhibitor medivir.com ↗
The poster by Simmen et al. entitled “Preclinical Characterization of TMC435350, a novel macrocyclic inhibitor of the HCV NS3/4A serine protease” demonstrates the ability of the compound to reduce the amount of Hepatitis C virus (HCV) replication in laboratory replicon experiments via protease inhibition. |
All press releases naming this drug 111 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 111 releases opens the full record — a long page | ||
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 104 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simeprevir | “The proposed study will quantify hepatic improvement and antiviral efficacy of the open-label interferon-free combination of 12 weeks of simeprevir (SMV, Simeprevir),...” NCT02455167 ↗49“Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 2016 “A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone...” NCT03155893 ↗ “TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection” NCT01846832 ↗ “7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant.” NCT03133065 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study.” PMID 25192745 ↗ Sep 2014 “Simeprevir (TMC435) is an oral NS3/4 protease inhibitor in phase III trials for chronic hepatitis C virus (HCV) infection.” PMID 24184810 ↗ Nov 2013 “Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naïve” PMID 24005956 ↗ Sep 2013 “150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions.” NCT02385071 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02932293 ↗ |
| Known as | F021 | “TMC435 (F021)” NCT01134718 ↗ |
| Known as | G006 | “TMC435 (G006)” NCT01134718 ↗ |
| Known as | G007 | “TMC435 (G007)” NCT01134718 ↗ |
| Known as | jnj-38733214-aaa | “TMC435 (also referred to as jnj-38733214-aaa)” NCT01366638 ↗2“TMC435 (also referred to as jnj-38733214-aaa)” NCT01292239 ↗ “TMC435 (also referred to as jnj-38733214-aaa)” NCT01288209 ↗ |
| Known as | OLYSIO | “OLYSIO (Simeprevir) (150mg QD)” NCT02214420 ↗ |
| Known as | Olysio is a trade name of simeprevir | “Olysio is a trade name of simeprevir” NCT04387539 ↗1“Olysio is a trade name of simeprevir” NCT04385407 ↗ |
| Known as | SIMEPREVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL501849 ↗ |
| Known as | SMV | “The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV)...” NCT03155893 ↗16“To investigate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or simeprevir (SMV) in a randomized, open-label, noninferiority trial” PMID 29906601 ↗ Jun 2018 “Part 1: Simeprevir (SMV) 75 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent capsule in Treatment C.” NCT03059303 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.” NCT02397395 ↗ “SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.” NCT02885454 ↗ “150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions.” NCT02385071 ↗ “combination of sofosbuvir (SOF) and simeprevir (SMV)” PMID 27782373 ↗ Dec 2016 “Simeprevir (SMV) 150 mg tablet orally once daily.” NCT02470858 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02932293 ↗ “Simeprevir (SMV) 150 mg tablet orally once daily” NCT02583685 ↗ |
| Known as | TMC-435 SODIUM SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL501849 ↗ |
| Known as | TMC435 | “During the second OC cycle, participants will receive again Ovysmen once daily during the first 21 days plus TMC435 150 mg once daily as of Day12 till and including Day21.” NCT01486004 ↗45“TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.” NCT01479868 ↗ “Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV)” NCT01938625 ↗ “TMC435 is being investigated for the treatment of chronic hepatitic C infection.” NCT01224197 ↗ “Simeprevir (TMC435)” NCT01707342 ↗ |
| Known as | TMC435350 | “TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection” NCT01846832 ↗6“different dose regimens of TMC435350 (hereafter referred to as TMC435) given alone or in combination with peginterferon alpha-2a (PegIFNa-2a) and ribavirin” NCT00561353 ↗ |
| Action | Inhibit | “blocking an enzyme (protease) that the HCV needs to replicate” NCT00561353 ↗ |
| Modality | Small molecule | “the macrocyclic HCV NS3/4A protease inhibitor TMC435” PMID 19852962 ↗ Oct 2009 |
| Route | Oral | “TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.” NCT00561353 ↗ |