Navigation Links
AbbVie's Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration
Date:5/6/2013

NORTH CHICAGO, Ill., May 6, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its investigational direct-acting antiviral (DAA) combination with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA).

The designation is based, in part, on positive data from AbbVie's clinical development program, including the Phase 2b clinical trial M11-652, known as "Aviator." The Aviator study was conducted in 571 patients infected with HCV GT1.  Results from the treatment arms evaluating ABT-450/r + ABT-267 + ABT-333 with and without ribavirin demonstrated that the regimen provided high sustained viral response rates (SVR) with 12 weeks of therapy in patients who had not been previously treated (treatment naive) and in those who had failed prior therapy with pegylated interferon and ribavirin (null responders), regardless of sex, HCV subtype, stage of fibrosis, viral load or IL28B genotype.  

According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.(1)

"AbbVie is pleased that the FDA has granted Breakthrough Therapy designation to our 3-DAA combination with and without ribavirin. We feel it reflects the potential of this regimen to be important in the treatment of HCV," said John M
'/>"/>

SOURCE AbbVie
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
2. Bayers Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
3. Positive Preclinical Data for NKTR-214, an Investigational Cancer Immunotherapy Targeting the IL-2 Receptor Complex, Presented at AACR Annual Meeting 2013
4. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
5. Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
6. Genocea Publishes Preclinical Data For Investigational Vaccine Candidate For HSV-2
7. Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause
8. Scioderms Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
9. BHR Pharma Investigational Traumatic Brain Injury Treatment Receives European Medicines Agency Orphan Medicinal Product Designation
10. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
11. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... 10, 2014 Yesterday, former Congressman ... device manufacturing facility. Rep. Kennedy and Dick ... facilitate cutting-edge research in neurological disease and treatment. ... health advocate, Garen Staglin , created One ... fundamental changes that will radically accelerate the development ...
(Date:7/10/2014)... , July 10, 2014  Decision Resources ... surveyed infectious disease (ID) specialists are willing to ... Orbactiv (oritavancin) for use as OPAT, approximately two-thirds ... these agents to their hospital inpatients. However, our ... OPAT patients are initiated on OPAT following hospital ...
(Date:1/15/2014)... , Jan. 15, 2014 Sono-Tek Corporation (OTC BB: ... ended November 30, 2013, compared to sales of $2,202,000 for ... Once again, this quarter has also shown growth over the ... first quarter of this fiscal year. Markets that experienced sales ...
Breaking Medicine Technology:Representative Patrick Kennedy visits Moberg's medical device facility to discuss improvement in brain injury care 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Sono-Tek Announces Third Quarter Results 2Sono-Tek Announces Third Quarter Results 3Sono-Tek Announces Third Quarter Results 4
... LONDON, March 2, 2012  ConvaTec, a world-leading developer ... and hospital care today announced that Amcare Ltd, ... has acquired SureCalm Healthcare Holdings Ltd and subsidiaries ... specialises in the home delivery of prescribable stoma ...
... Mich., March 2, 2012 Rubicon Genomics, Inc., ... to improve the capabilities and performance of DNA ... has selected Velesco Pharmaceutical Services to manufacture the ... with Agendia,s breast cancer diagnostics.  Velesco is a ...
Cached Medicine Technology:ConvaTec Announces Acquisition of SureCalm Healthcare 2Rubicon Genomics Selects Velesco to Manufacture its TransPLEX® RNA Amplification Kits for Clinical Diagnostic Use 2Rubicon Genomics Selects Velesco to Manufacture its TransPLEX® RNA Amplification Kits for Clinical Diagnostic Use 3
(Date:7/12/2014)... (PRWEB) July 12, 2014 “Critical ... - New and Late-Stage Four-Factor PCCs and Recombinant ... of the critical care market in the US, ... The report provides an estimation of market size ... It covers critical care indications that are being ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Dubai is ... basketball legend is heading to the UAE. The ... champion will be in the UAE from 28-31 October ... in support of diabetes awareness. The event is being ... marketing and event management company based in Dubai. The ...
(Date:7/12/2014)... Seattle, Wa (PRWEB) July 12, 2014 ... by Doctors Sen and Samantha Pearson, a couple boasting ... chose to launch Restore My Vision Today as a ... that many ophthalmologists have become in their respective ... makes readers privy to a “secret” trove of pertinent ...
(Date:7/12/2014)... 2014 Ladies, it doesn't matter what your ... who are looking for an affordable gown can visit ... dresses) to get their dream items. Recently, the company has ... gowns . Along with that, it is also providing great ... special offer; the deadline of this promotion is July 29, ...
(Date:7/11/2014)... 2014 According to new report ... is expected to register a CAGR of 2.28% ... 71 market data tables and 76 figures spread ... Market"., http://www.marketsandmarkets.com/Market-Reports/c4isr-market-1315.html , Early buyers will ... , The report provides market analysis of ...
Breaking Medicine News(10 mins):Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 3Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 4Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 5Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 6Health News:Los Angeles Basketball Legend Headed to Dubai 2Health News:Los Angeles Basketball Legend Headed to Dubai 3Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 3Health News:Worldwide Brides-to-be: It Is Time To Show Your Beauty By Wearing A Trendy Summer Short Wedding Dress From Discount-Dress.com 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 3Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 4
... Income Protection, Offers Tips for Obtaining Coverage , ARLINGTON, Va., ... survey show the historic recession has left many Americans with ... they are more vulnerable to serious financial hardship in the ... work. According to the nonprofit LIFE Foundation, more than a ...
... and Afghanistan ... To help ease the transition and readjustment challenges facing Iraq ... of America (IAVA) joined the Ad Council today to launch a ... Support Campaign. Launched on Veterans Day 2008, the first series of ...
... distinguished professor at Kansas State University,s Division of Biology, ... from The National Eye Institute of the National Institutes ... renewal will make Conrad,s grant the longest continuously funded ... years," said Jim Guikema, K-State associate vice president for ...
... of a statin in time of crisis improved long-term ... -- Giving patients a cholesterol-busting statin drug during a ... of longer-term problems, Czech researchers say. , The one-year ... than halved for people suffering life-threatening episodes of acute ...
... Data Presented at American Heart Association ATVB Conference Shows ... Lesions in Treated PatientsWASHINGTON and SAN FRANCISCO, May 1 ... today announced the results of a sub-study of patients ... who received serial 64 slice multidetector computed tomography (MDCT) ...
... Wash., May 1 SCOLR Pharma, Inc. (NYSE Amex: ... ended March 31, 2009. The Company will host a ... (Eastern Daylight Time).Bruce S. Morra, SCOLR Pharma,s President and CEO, ... our two lead product candidates, ibuprofen and pseudoephedrine, and the ...
Cached Medicine News:Health News:Hit Hard by the Economy, Americans Risk Knockout Without Disability Insurance 2Health News:Hit Hard by the Economy, Americans Risk Knockout Without Disability Insurance 3Health News:Hit Hard by the Economy, Americans Risk Knockout Without Disability Insurance 4Health News:Video: IAVA and Ad Council Build on Success of Groundbreaking Veterans Campaign with New Friends and Family Element 2Health News:Video: IAVA and Ad Council Build on Success of Groundbreaking Veterans Campaign with New Friends and Family Element 3Health News:Video: IAVA and Ad Council Build on Success of Groundbreaking Veterans Campaign with New Friends and Family Element 4Health News:K-State professor awarded $1.48 million to study LASIK complictions 2Health News:K-State professor awarded $1.48 million to study LASIK complictions 3Health News:Cholesterol Drugs May Help in Cardiac Emergency 2Health News:VIA Pharmaceuticals Announces Positive Phase 2 Results of VIA-2291 in Cardiovascular Patients Using Serial MDCT Imaging of Coronary Plaque 2Health News:VIA Pharmaceuticals Announces Positive Phase 2 Results of VIA-2291 in Cardiovascular Patients Using Serial MDCT Imaging of Coronary Plaque 3Health News:VIA Pharmaceuticals Announces Positive Phase 2 Results of VIA-2291 in Cardiovascular Patients Using Serial MDCT Imaging of Coronary Plaque 4Health News:VIA Pharmaceuticals Announces Positive Phase 2 Results of VIA-2291 in Cardiovascular Patients Using Serial MDCT Imaging of Coronary Plaque 5Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 2Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 3Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 4Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 5Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 6Health News:SCOLR Pharma, Inc. Reports First Quarter 2009 Financial Results 7
Blood grouping tubes are available in two formulations, ACD-A, ACD-B or with a CPDA solution. Blood grouping tubes are for blood grouping determinations and also for cell preservation....
BD Vacutainer® Specialty Tubes - Other - Glass...
BD Vacutainer® Specialty Tubes - Other - Plastic...
BD Vacutainer® Specialty Tubes - Lead Testing...
Medicine Products: