Navigation Links
Simeprevir Data in Hepatitis C Patients to be Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
Date:10/1/2013

meprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except for in the Nordic countries. Medivir will retain marketing rights for simeprevir in these countries. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

Additionally, simeprevir is being studied in combination with several direct-acting antiviral agents (DAAs) with different mechanisms of action, with and without ribavirin, as part of interferon-free regimens. These include:

  • The Phase 2 COSMOS study of simeprevir and Gilead's nucleotide polymerase inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 HCV patients, including patients with cirrhosis; 
  • A Phase 2 study of simeprevir and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 HCV patients; 
  • The Phase 2 HELIX-1 study of simeprevir and Idenix's once-daily pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naive genotype 1b and genotype 4 HCV patients.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C
Hepatitis C, a blood-borne in
'/>"/>

SOURCE Janssen R&D Ireland
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
2. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
3. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
4. Findings from Two Phase 3 Studies of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
5. Janssen and Johnson & Johnson to Provide Webcast Presentation of Simeprevir Phase 3 Clinical Data Presented at The International Liver Congress of the European Association for the Study of the Liver (EASL)
6. U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
7. Primary Efficacy and Safety Findings from Phase 3 Study of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
8. Aethlon Medical Note: An Unprecedented Data Point, The Single-Treatment Capture of Hepatitis C Virus (HCV) by the Aethlon Hemopurifier®
9. Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy
10. Bulgaria Launches Development of National Hepatitis Plan
11. Major Breakthrough in Hepatitis C Vaccine Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Dec. 23, 2014   Synageva BioPharma Corp. ... company developing therapeutic products for rare disorders, today ... of the Marketing Authorization Application (MAA) for sebelipase ... the company,s request for accelerated assessment, which has ... time.   The MAA, and the ...
(Date:12/24/2014)... Dec. 23, 2014 Tianyin Pharmaceutical Co., ... specializes in patented biopharmaceutical, modernized traditional Chinese medicine ... today announced that the Company achieved the Public ... Practice (GMP) certificate of TPI,s Qionglai Facility (QLF) ... The public notice period is a significant procedure ...
(Date:12/22/2014)... 22, 2014  CytoSorbents Corporation (OTCQB:CTSOD), a critical ... purification technology to help fight deadly inflammation in ... worldwide, today announced the appointment of Dr. ... its Senior Vice President of Clinical Development, effective ... Di Russo is an accomplished pediatric cardiothoracic ...
Breaking Medicine Technology:Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 5
... PHILADELPHIA, Pa. June 20 GlaxoSmithKline,(NYSE: GSK ... and Drug,Administration has extended the priority review period ... treated patients,with chronic idiopathic thrombocytopenic purpura, as they ... Drug User Fee action date has,been extended to ...
... OAK LAWN, Ill., June 20 Advocate Christ,Medical Center ... a few institutions,in the Chicago area, the only one ... hospitals nationally that are using a glue-like liquid for,the ... a recent two-and-a-half-hour procedure, Thomas J. Grobelny MD, of,the ...
Cached Medicine Technology:GSK Update on FDA Review of Promacta(R) (Eltrombopag) 2Advocate Christ Medical Center Using Glue-Like Liquid to Seal Off Brain Aneurysms 2
(Date:12/25/2014)... December 26, 2014 The ... combines beauty, strength and durability. Today, the business ... which is valid until Jan. 30, 2015. , ... of traditional hardwood. BambooFlooringChina.com is a well-known brand ... consumers worldwide to find a reliable bamboo flooring ...
(Date:12/25/2014)... iFitDress.com, the popular online supplier of wedding dresses and special ... black one-shoulder cocktail dresses . In addition, all these ... discounted prices, up to 70% off. , The ... only. You know, we have thousands of frequent callers in ... items can visit our website for more details. The current ...
(Date:12/25/2014)... 25, 2014 Helen Harris’ RP (Retinitis ... Hills, California after an 8 year battle with breast ... Eve evening in her home in Woodland Hills California ... cancer. , As the founder and ... she pioneered and championed many of today's greatest breakthroughs ...
(Date:12/25/2014)... 25, 2014 (HealthDay News) -- Overeating is common during the ... in moderation, an expert says. "Don,t arrive at a ... if you know you,ll be attending a party, but deprivation ... lead dietitian at Northern Westchester Hospital in Mount Kisco, N.Y., ... eat healthy during the day and even to have a ...
(Date:12/25/2014)... December 25, 2014 “ SmileStix ” was ... features the latest and coolest mobile applications on the iOS, ... and host of NewsWatch, conducted the app review and shared ... create personal stickers. , The old saying goes, “A picture ... of words that can describe a single image, because each ...
Breaking Medicine News(10 mins):Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2
... for bowel cancer at Queen,s University Belfast has received ... Dr Sandra Van Schaeybroeck, whose research aims to identify ... a prestigious 688,000 Cancer Research UK Clinical Scientist Fellowship. ... four fellowships awarded to UK clinical investigators, renews Dr ...
... ,Surgeons aged 35 to 50 provide the safest care for ... about ongoing training and motivation of surgeons during their careers, ... France. They analyzed data from 3,574 thyroidectomies (removal of ... over a one-year period. The average age of the surgeons ...
... , TUESDAY, Jan. 10 (HealthDay News) -- Children with autism ... bacteria seen in kids who do not have the disorder, ... 10 in the online journal mBio , researchers from ... New York City suggested that this finding could help explain ...
... patients improved between 2003 and 2008, according to a ... Outcomes , an American Heart Association journal. The study ... of care, and that differences in care between the ... because little is known about the treatment and outcomes ...
... By Serena Gordon HealthDay Reporter , TUESDAY, Jan. ... new research suggests those costs may extend far beyond the ... study authors found that young people with diabetes were more ... lifetime, could expect to earn about $160,000 less than those ...
... that older Americans with cirrhosis have significantly worse health ... this potentially deadly disease. In fact, findings now published ... American Association for the Study of Liver Diseases, show ... of informal caregiving and contribute added strain on the ...
Cached Medicine News:Health News:Groundbreaking cancer research receives massive funding boost 2Health News:Surgeons in Mid-Career Have Fewest Complications: Study 2Health News:Autism Gastro Problems May Be Linked to Gut Bacteria 2Health News:Asian-Americans getting better heart attack care 2Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 2Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 3Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 4Health News:High rates of disability and health care use for older americans with cirrhosis 2
... Complete procedure information to facilitate diagnostic ... monitor is a sterile, disposable device used ... nucleus during discography procedures. The device will ... display it in a digital format. The ...
Smith & Nephew's CDS System is developed exclusively for discography., Developed exclusively for discography, it is the first system designed to measure true disc pressure and record real-time proce...
The ACCU-DISC™ pressure monitoring system offers the advantage of accurate delivery of fluids to the body with the ability to monitor the pressure of those fluids in discography interpretation....
The °CureWrap is one-piece garment offers maximum available surface coverage, while avoiding the sterilized fields of operation....
Medicine Products: