Navigation Links
Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
Date:2/3/2009

in Boston and senior investigator with BWH's TIMI Study Group. "In a large head-to-head trial, TRITON, showed that prasugrel was superior to clopidogrel, the current standard of care. While the benefit of prasugrel is accompanied by an increased risk of serious bleeding events, appropriate selection of patients and doses may help mitigate this risk."

The committee reviewed comprehensive data primarily from the TRITON TIMI- 38 clinical trial. Results from the TRITON trial showed that prasugrel taken with aspirin reduced the relative risk of the combined endpoint of cardiovascular death, non-fatal heart attacks or non-fatal stroke by 19 percent more than clopidogrel (Plavix(R)/Iscover(R)) taken with aspirin. These benefits were accompanied by an increased risk of serious bleeding with prasugrel overall, some of which included life-threatening and even fatal bleeding. When the risk of this type of bleeding was compared to the benefit of reduced heart attack, there were five more TIMI major bleeding events, but 22 fewer heart attacks for every 1,000 patients treated with prasugrel compared to every 1,000 patients treated with clopidogrel.(i) The overall risk of cardiovascular death and the risk of increased stroke were not statistically different between treatment groups.

FDA reviewers will consider the panel's favorable recommendation in its review of the new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo, Limited, on December 26, 2007.

The Burden of Acute Coronary Syndromes

Acute coronary syndromes (ACS), which includes heart attack and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(ii) Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(iii) Coronary artery disease
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel
2. In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack
3. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
4. DaVita Receives Civil Complaint
5. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
6. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
7. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
8. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
9. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
10. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
11. Prime Therapeutics Receives TIPPS Certification
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/12/2014)... HealthDay Reporter SATURDAY, July ... that a surgical technique used to grind up uterine growths ... of spreading cancer to other parts of a woman,s body, ... the Food and Drug Administration also said that women who ... should sign a written consent stating that they understand the ...
(Date:7/12/2014)... The fastest-growing mobile technology is LTE ... of LTE networks continues to grow due to the ... have increased mobile data traffic, which is a major ... Communications Test and Measurement equipment comply with industry standards, ... Test and Measurement Market is estimated to grown from ...
(Date:7/12/2014)... PA (PRWEB) July 12, 2014 "The second ... it’s uncomfortable and painful to wear shoes," said an inventor ... special sock that prevents this from happening. , He then ... effective way to prevent the second and big toes from ... endurance while wearing shoes. Ergonomic and easy to use, it's ...
(Date:7/12/2014)... With prom shopping reaching its final days, ... ready to showcase its new and trendy apparels. Recently, ... dresses in its online shop. Additionally, it is now ... elegant gowns. According to the company’s sales manager, the ... 2014. , He says, “Now, worldwide clients can ...
(Date:7/12/2014)... York, NY (PRWEB) July 12, 2014 As ... (the National Institute of Standards and Technology), the June 25th, ... the electronic discovery world. It was also ... finally in, depending on whether it was seen from an ... But this much is fact, there is now precedent which ...
Breaking Medicine News(10 mins):Health News:FDA Advisers Weigh Risks of Procedure for Removal of Uterine Fibroids 2Health News:FDA Advisers Weigh Risks of Procedure for Removal of Uterine Fibroids 3Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 5Health News:VogueQueen.com Updates Its Summer Collection With New And Trendy Evening Dresses 2Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 2Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 3Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 4Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 5
... is deeply disturbed that the Food and Drug ... vulnerable populations such as women of child-bearing age, ... recommendation flies in the face of decades of ... of mercury from food, especially on the developing ...
... Univita Health will provide an integrated approach to home-based care and ... 15 The launch of a new company aimed at promoting ... Univita Health is introducing new programs and innovating existing services to ... , "Due to falling birthrates and increased ...
... per cent of the men who took part in the ... trial were diagnosed with the disease and the majority of ... published in the December issue of the urology journal ... women aged from 55 to 74 took part in the ...
... Dec. 15 Today, a parent of a mercury-poisoning victim joined ... proposal to stop warning pregnant women and children about exposure risks ... "We,ve known for years that mercury is toxic to ... individual,s status. For FDA to suddenly change the equation to ...
... hair loss for,both men and women is a very traumatic ... help our clients that worked unlike many potions,lotions and product ... it is the only true hair regeneration laser on the ... Medical, Northwestern,University , Mass General, etc.). They are ...
... 15 Greenway Medical Technologies,Inc. today announced that ... (EHR) solution, PrimeSuite(R), won,three "Best in KLAS" awards ... KLAS Awards,report. For the third consecutive year, ... ambulatory EMR category for practices having between six ...
Cached Medicine News:Health News:CU Statement on FDA Position on Mercury From Fish Consumption 2Health News:Launch of New 'Independent Aging' Company Will Address the Needs of the Growing Senior Population 2Health News:Launch of New 'Independent Aging' Company Will Address the Needs of the Growing Senior Population 3Health News:USA's largest ever prostate cancer screening program shows high compliance and consistent results 2Health News:USA's largest ever prostate cancer screening program shows high compliance and consistent results 3Health News:FDA's Proposed Mercury Fish Advice Based on Flawed Science, Say MD and Anti-Mercury Advocates 2Health News:Greenway Medical Technologies' EHR Solution, PrimeSuite, Wins Three 'Best in KLAS' Awards 2Health News:Greenway Medical Technologies' EHR Solution, PrimeSuite, Wins Three 'Best in KLAS' Awards 3Health News:Greenway Medical Technologies' EHR Solution, PrimeSuite, Wins Three 'Best in KLAS' Awards 4
(Date:7/10/2014)... JORDAN, Utah , July 10, 2014  BC ... solutions, and MiE America , Inc., a leading ... have entered into a long-term agreement naming BC Technical ... the US. MiE and BC Technical ... strategic agreement to establish BC Technical as the service ...
(Date:7/10/2014)... 10, 2014   LabStyle Innovations Corp . ... announced the appointment of Professor Richard B. ... Board of Directors. Prof. Stone brings ... to LabStyle as an entrepreneur, venture capitalist public, ... governance expert. He currently serves on the board ...
(Date:1/15/2014)... 15, 2014 /PRNewswire-iReach/ -- ChinaMarketResearchReports.com adds "China Orthopedic Instrument ... (Photo: http://photos.prnewswire.com/prnh/20140115/MN46792 ) ... support, China,s orthopedic instrument industry ... market size rising from 3.28 billion yuan in 2006 ...
Breaking Medicine Technology:BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 2LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 3LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 4Orthopedic Instrument Industry in China Markets Forecast to 2015 2Orthopedic Instrument Industry in China Markets Forecast to 2015 3
... Sept. 7 According to Millennium Research Group (MRG), ... in Japan,s Ministry of Health Labour and Welfare (MHLW) ... catheters, will lead to double-digit growth in this segment ... market revenues. Unlike in the US ...
... Reportlinker.com announces that a new market research ... Drug Delivery in Central Nervous System Diseases ... http://www.reportlinker.com/p0203542/Drug-Delivery-in-Central-Nervous-System-Diseases---technologiesmarkets-and-companies.html SummaryThe delivery ... a challenge in the treatment of neurological disorders. ...
Cached Medicine Technology:Will MHLW Changes in Reimbursement Drive Japanese Physicians to Increase Usage of Chronic Dialysis Catheters? 2Will MHLW Changes in Reimbursement Drive Japanese Physicians to Increase Usage of Chronic Dialysis Catheters? 3Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 2Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 3Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 4Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 5Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 6Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 7Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 8Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 9Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 10Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 11Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 12Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 13Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 14Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 15Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 16Reportlinker Adds Drug Delivery in Central Nervous System Diseases - technologies,markets and companies 17
... Pro Osteon Bone Graft Substitutes a natural ... from cadaver bone, but such grafts may ... disease transmission. Interpore Cross has developed the ... to address these needs, offering surgeons a ...
... Healos is an osteoconductive matrix constructed ... fully coated with hydroxyapatite through a ... with autogenous bone marrow aspirate, Healos ... cell attachment, proliferation and differentiation. The ...
Weitlaner-Locktite retractors, blunt, 11 cm total length....
Sharp Weitlaner Retractor....
Medicine Products: