Navigation Links
FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients
Date:10/24/2013

RARITAN, N.J., Oct. 24, 2013 /PRNewswire/ -- 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. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-naive or who have failed previous interferon-based therapy.

"We are pleased with the positive recommendation from the Advisory Committee for simeprevir and appreciate the rigorous review of our data," said Katia Boven, M.D., Medical Department Head, Infectious Diseases and Vaccines, Janssen. "It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C."

The FDA granted a Priority Review designation in May to the New Drug Application (NDA) filed by Janssen for simeprevir. Recommendations and findings from the Advisory Committee are based in part on efficacy and safety data from an extensive clinical development program for simeprevir and will be considered by the FDA in its review of the NDA for simeprevir, but the FDA is not required to follow them.  

The regulatory submission for simeprevir is supported in part by data from three pivotal Phase 3 studies – QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients who have relapsed after prior interferon-based treatment – as well as data from the Phase 2b ASPIRE study in prior non-responder patients. Janssen R&D Ireland presented data
'/>"/>

SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Vaccinogen Names Dr. Benjamin Carson and Dr. Jan B. Vermorken to Medical Advisory Board
2. BSMA Expands Advisory Board to Advance BIOTECH SUPPLY CHAIN
3. Egenix, Inc. Appoints Matthew Fury, M.D., Ph.D. to its Scientific Advisory Committee
4. Boyd "Rainmaker" Melson, Professional Athlete and Advocate for Spinal Cord Injury Treatment, Signs on as Advisory Board Member of Store-A-Tooth™ Dental Stem Cell Banking
5. PennWells Strategies in Biophotonics Event Adds Two New Advisory Board Members
6. Dr. David R. Bassett Joins ActiGraph Scientific Advisory Board
7. Creabilis Appoints Professor Gil Yosipovitch and Professor Praveen Anand to its Scientific Advisory Board
8. Generex Confirms Conference Call with Members of the Antigen Express Scientific Advisory Board
9. Generex Announces Particulars of Conference Call with Members of the Antigen Express Scientific Advisory Board
10. Dr. Victor KR Matsudo Joins ActiGraph Scientific Advisory Board
11. Hemostemix Announces Formation of Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... , a precision medicine software company that has developed a ... genomic, imaging and other biomedical data in research and clinical ... CEO of Aspera, an IBM Company, to its board as ... "We are pleased to welcome Michelle to ...
(Date:12/25/2014)... 2014 The report “Service Quality Management ... & Provider Type - Global Advancements, Worldwide Forecasts & ... in-depth analysis and forecasting of revenues. , Browse ... pages and in-depth TOC on “Service Quality Management (SQM) ...
(Date:12/24/2014)... , Dec. 24, 2014 PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI, ... announced the closing of an underwritten public offering of 3,500,000 ... an aggregate 3,500,000 shares of common stock, at an offering ... warrants have a per share exercise price of $5.00, are ...
(Date:12/24/2014)... Dec. 24, 2014   BioLife Solutions , Inc. (NASDAQ: ... proprietary clinical grade hypothermic storage and cryopreservation ... for cells and tissues  ("BioLife" or the "Company"), today announced ... on May 4, 2015 (the "Annual Meeting"). Because ...
Breaking Biology Technology:GenoSpace Expands Board with Appointment of Michelle Munson 2Service Quality Management Market worth $2.1 Billion & Telco Customer Experience Management Market worth $2.3 Billion by 2019 – New Report by MarketsandMarkets 2Service Quality Management Market worth $2.1 Billion & Telco Customer Experience Management Market worth $2.3 Billion by 2019 – New Report by MarketsandMarkets 3Service Quality Management Market worth $2.1 Billion & Telco Customer Experience Management Market worth $2.3 Billion by 2019 – New Report by MarketsandMarkets 4PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 2PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 3BioLife Solutions Sets Date for Annual Meeting of Stockholders 2
... Potential Blockbuster Product for High Risk Cardiovascular ... ... Calif., Jan. 7 ,Genzyme Corp. (Nasdaq: GENZ ) and Isis ... a major strategic alliance in which,Genzyme will develop and commercialize mipomersen, ...
... Jan. 7 Cephalon, Inc. (Nasdaq:,CEPH) announced today that ... at the JPMorgan Healthcare Conference are now available on ... . On Tuesday, January 8, 2008, Frank Baldino, Jr.,Ph.D., ... at the,Conference beginning at 2:00 p.m. Pacific Time (5 ...
... of Investment Success -, GAITHERSBURG, Md., Jan. ... of AstraZeneca plc (LSE: AZN.L, NYSE:,AZN), today announced ... will broaden its focus to include areas of ... areas of,cardiovascular and metabolic disease, pain and central ...
Cached Biology Technology:Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 2Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 3Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 4Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 5Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 6Genzyme and Isis Announce Strategic Alliance Including Exclusive Worldwide License of Mipomersen 7Cephalon Presentation Slides for the 26th Annual JPMorgan Healthcare Conference Now Available 2MedImmune Broadens Focus of Venture Capital Fund to Include New Therapeutic Areas 2MedImmune Broadens Focus of Venture Capital Fund to Include New Therapeutic Areas 3
(Date:12/17/2014)... 2014 The Defense Logistics Agency is insourcing its ... counterfeit microcircuits from entering into its supply chain. ... anti-counterfeit initiative dubbed DNA marking. The capability will validate ... throughout the supply chain. The new quality control measures ...
(Date:12/17/2014)... 16, 2014 Valencell, a leader in performance biometric ... to industry leaders such as Intel, Jabra, Atlas, and ... wearable products. These products will be showcased at CES ... Vegas . "Our partners choose ...
(Date:12/17/2014)... 2014  Automation is fundamentally transforming the travel experience and ... Over the past decade, ePassports, biometric readers, and secure ... through border control via eGates and Automated Passport Control ... and land borders across the globe. ...
Breaking Biology News(10 mins):Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 2Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 3Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2
... in the most exciting and unsettling period in the ... in public. On the one hand, the ... the psychiatric diagnostic manual, DSM-V, representing the current best ... categorize the enormously complex pattern of human emotional, cognitive, ...
... University of Adelaide has shown for the first time ... greatly increasing the risk of complications for themselves and their unborn ... world, researchers from the University,s Robinson Institute compared data ... results have been published online ahead of print in the ...
... time that the blood vessels that transport blood to and ... just bodily pipelines. Arterioles and capillaries, the small vessels, actually ... blood they,re carrying. Biomedical engineers at Drexel University, who study ... how they do it. The team, which includes Drs. ...
Cached Biology News:What is the brain telling us about the diagnoses of schizophrenia and bipolar disorder? 2Smoking + asthma + pregnant = a dangerous combination 2Drexel researchers looking inside vessels to understand blood's ebb and flow 2
Request Info...
Many mammalian cell types and experimental situations create challenges for standard transfection experiments. The ViraPower Lentiviral Expression System overcomes these challenges with efficient vir...
...
Request Info...
Biology Products: