Navigation Links
FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
Date:6/23/2008

Companies confirm the start of TRILOGY ACS clinical trial to study

Prasugrel against Clopidogrel in medically managed ACS patients

TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, (TSE:4568) and Eli Lilly and Company (NYSE: LLY) said that the U.S. Food and Drug Administration (FDA) has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period. This three month extension allows the FDA time to complete its review. The prasugrel NDA was granted priority review by the FDA in February 2008. The new FDA action date for prasugrel is September 26, 2008. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery- opening procedure known as percutaneous coronary intervention (PCI).

Daiichi Sankyo and Lilly also confirm the start this month, as planned, of the TRILOGY ACS trial, a large Phase III clinical trial to compare the effects of prasugrel against clopidogrel (Plavix(R)/Iscover(R)) in medically managed ACS patients.

"We remain confident in our prasugrel submission package," said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "The TRITON trial encompassed a large amount of data from over 13,000 patients. We will continue to work closely with the FDA throughout the review process and continue discussions to determine if any requirements under the new FDA Amendment Act (FDAAA) legislation will apply."

"The initiation of the TRILOGY ACS trial demonstrates our continued commitment to investigate prasugrel as a potential therapy for ACS patients who are medically managed," said John A
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Everolimus (RAD001) Significantly Extends Progression-Free Survival in Advanced Kidney Cancer Patients After Failure of Other Targeted Therapy
2. Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study
3. FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
4. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
5. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
6. Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
7. GSK Update on FDA Review of Promacta(R) (Eltrombopag)
8. ASPIRE Independent Review Board Announces 10 Ways to Protect Participants Rights in Clinical Drug Trials and Optimize Results From Research
9. CNS Response, Inc. Provides Review of Poster Session Delivered at the American Psychiatric Association 161st Annual Meeting
10. Got Fat?: Plastic Surgeons Review Fat-Melting and Fat-Grafting Procedures
11. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014 PuraMed BioScience®, Inc., (OTC Pink: PMBS), ... and healthcare products, announced it received the initial funding ... advanced headache relief product, for planned distribution to 1,000 ... , Washington State , and ... MigraPure H Advanced headache relief gel formulation completed, PuraMed ...
(Date:12/24/2014)... 2014 ResMed (NYSE: RMD ) today ... Chinese medical device manufacturer BMC Medical Co., Ltd. ... masks listed below infringe ResMed,s patents, and entered an order ... the United States : , ... , Willow nasal pillows mask , iVolve full face ...
(Date:12/24/2014)... MASON, Ohio , Dec. 23, 2014 /PRNewswire/ ... industry-leading treatment decision support to healthcare providers for ... that it has secured $30 million in equity ... Virginia C. Drosos , President and Chief ... increased clinical adoption and development of Assurex Health,s ...
Breaking Medicine Technology:PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 2Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 3Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 4
... PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI ... company,s president and chief executive officer, is scheduled ... Markets Healthcare ConferenceWednesday, March 2, 20119:00 a.m. Eastern ... Health Care Conference Tuesday, March 8, 201111:00 a.m. ...
... Feb. 24, 2011 Novation, the leading health care ... cancelled five contracts with Novation that cover cardiovascular and ... the University HealthSystem Consortium (UHC), and VHA and UHC ... in these product categories. Novation has been in constant ...
Cached Medicine Technology:Medtronic Inc. Cancels Cardiovascular and Orthopedic Contracts With Novation 2Medtronic Inc. Cancels Cardiovascular and Orthopedic Contracts With Novation 3
(Date:12/26/2014)... December 26, 2014 India Network Foundation, ... in the USA, announced today a new version of ... in choosing the right plan for their visiting parents. ... out of the selection process when choosing an insurance ... group with only a few clicks. Many elderly Asian ...
(Date:12/25/2014)... 2014 This is a professional and ... Sterilizers industry with a focus on the Chinese market. ... of the Sterilizers manufacturers and is a valuable source ... in the industry. This report provides a basic overview ... technology. In this part, the report presents the company ...
(Date:12/25/2014)... “Every three months the trends for evening ... dress will be one of the hottest styles in the ... Today, the company releases 26 A-line sweetheart evening dresses, and ... , “We are trying our best to help a ... designs. Along with affordable prices, we provide discounted delivery costs ...
(Date:12/25/2014)... BambooFlooringChina.com sells many bamboo products and the business ... company announces big discounts on its bamboo mats ... BambooFlooringChina.com is the world’s leader in bamboo flooring. According ... Jan. 20, 2015. , The bamboo mats are made ... thread. All the bamboo strips for the mats are ...
(Date:12/25/2014)... Dec. 25, 2014 (HealthDay News) -- The risk of ... holidays, so you need to be extra cautious, an ... we see a significant increase in patients coming in ... the Suffolk County Volunteer Firefighters Burn Center of Stony ... should be full of joy, but if not careful, ...
Breaking Medicine News(10 mins):Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 3Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 2Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 3Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:Don't Let Burns Mar Your Holidays 2
... but not frequency, study suggests , , THURSDAY, April ... 2-year-olds relate to each other affects the quality -- ... "terrible twos." And a child,s temperament plays a role ... to a new study. , Interactions between 60 mothers ...
... 3, 2008 With spring here and,summer fast approaching, ... said, attractive feet are a MUST!, YogaToes(R) are ... feel great. YogaToes(R) beautify feet with passive exercise that,helps ... by tight,shoes, high heels and overexertion., "Women aren,t ...
... MedQuist,Inc. (Pink Sheets: MEDQ.PK) announces that ... hospital in Newburyport, Mass., has selected MedQuist,Technology ... solution,including dictation, transcription and speech recognition. Anna ... and is home to a,nationally recognized Wound ...
... Third Bank,today announced a strategic alliance with GHN-Online ... cycle management services to,the healthcare industry, that will ... healthcare providers. The alliance,will enable Fifth Third Bank ... to payments -- and integrate the data into ...
... Expands Global Product Potential, LEXINGTON, Mass., April ... ) today announced the signing of a,License, Supply ... rights to market VANTAS(R) (histrelin acetate subcutaneous,implant) throughout ... is a,12-month implant for the treatment of advanced ...
... a child for a lifetime, researchers say, , , THURSDAY, April ... United States were victims of maltreatment in 2006 during their ... or neglect during their first week of life, federal officials ... examination of the risk for nonfatal maltreatment of children less ...
Cached Medicine News:Health News:Mother-Child Bond Affects Quality of Conflict Resolution 2Health News:New Ten-Minute Foot Exercisers Beautify Feet for Spring and Summer Sandal Season 2Health News:MedQuist Technology Solutions to Power Documentation Workflow at New England Facility 2Health News:MedQuist Technology Solutions to Power Documentation Workflow at New England Facility 3Health News:Fifth Third Bank Teams with Leading Healthcare Providers to Deliver a Claims-to-Payment Business Intelligence Platform 2Health News:Fifth Third Bank Teams with Leading Healthcare Providers to Deliver a Claims-to-Payment Business Intelligence Platform 3Health News:Indevus Pharmaceuticals Licenses European Rights for VANTAS(R) to Orion Corporation 2Health News:Indevus Pharmaceuticals Licenses European Rights for VANTAS(R) to Orion Corporation 3Health News:Indevus Pharmaceuticals Licenses European Rights for VANTAS(R) to Orion Corporation 4Health News:More Than 90,000 U.S. Infants Are Victims of Abuse or Neglect 2Health News:More Than 90,000 U.S. Infants Are Victims of Abuse or Neglect 3
... tension-free sling technology marries with ... collagen matrix sling, for exceptional ... between sling and host, reduces ... vaginal abrasion or erosion and ...
... are designed specifically for rehabilitation facilities. These ... deck that provides the ideal cushioning for ... user-friendly control panel displays all pertinent information ... features a "soft start" the belt ...
... The FineTech-Brindley (also known as the VOCARE) ... has been used by people with spinal ... urinate) on demand. A secondary use of ... evacuation and promote penile erection.,The Bladder System ...
Used for dilation of a tract to the kidney for removal of stones. Supplied sterile in peel-open packages. Intended for one-time use....
Medicine Products: