Navigation Links
Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
Date:5/5/2009

ne, compared to a reduction of 1.5 percentage points for BYETTA, and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with BYETTA. Exenatide once weekly and BYETTA were both associated with an average weight loss of 8 pounds from baseline. The most commonly reported adverse event was nausea, which was typically mild and transient and occurred less frequently in the exenatide once weekly patients. In addition, a meta-analysis across controlled clinical studies of three months or greater from the BYETTA database showed no increased risk of cardiovascular events associated with exenatide use. This analysis applied principles outlined in the FDA's guidance for evaluating cardiovascular risk in type 2 diabetes agents.

Components of the submission supporting product manufacturing include analyses to demonstrate comparability of the intended commercial product with that used during development. These analyses include data from patients in the ongoing extension of the DURATION-1 study who used exenatide once weekly produced at Amylin's manufacturing facility in Ohio.

"If approved, exenatide once weekly would be the first and only once-a-week therapy for the treatment of type 2 diabetes," said David Vondle, exenatide global brand development leader for Lilly. "A new treatment option to help patients with type 2 diabetes manage blood sugar, with potential weight loss and less frequent dosing, could offer an important advance in the treatment paradigm for patients and physicians who manage this chronic condition."

About Diabetes

Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and costs approximately $174 billion per year in dire
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. New Data From Head-to-Head Phase 3 Trial Demonstrate That Liraglutide is More Effective Than Exenatide in Treatment of Type 2 Diabetes
2. Lilly and Amylin Enter Into Supply Agreement for Exenatide Once Weekly
3. Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events
4. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
5. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
6. KineMed to Collaborate With Merck KgaA to Validate New Applications for Drug Development Candidates
7. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
8. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
9. Isis Announces $4.2 Million in Government Contracts Awarded to Its Ibis Subsidiary for Biodefense Applications Development
10. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
11. Nitecs IND Application for Clinical Development With Lodotra Accepted by the FDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2014)... DUBLIN , Aug. 19, 2014 Research ... Oxide Fuel Cells (SOFCs) - Global Strategic Business Report" ... the worldwide markets for Solid Oxide Fuel Cells (SOFCs) in ... US, Canada , Europe ... Annual estimates and forecasts are provided for the period 2012 ...
(Date:8/19/2014)... , Aug. 19, 2014 ... the addition of the "Spectroscopy Equipment ... report to their offering. ... for Spectroscopy Equipment and Accessories in US$ ... Spectroscopy (UV-Vis spectrophotometers, Raman Spectrometers, NMR-EPR Spectrometers, ...
(Date:8/19/2014)... ROCKVILLE, Md. , Aug. 19, 2014 /PRNewswire/ ... a biotechnology company developing novel anti-infective biologic and ... infections and diseases, announced today that its novel ... highlighted at the 54 th Interscience Conference ... in Washington D.C. ...
(Date:8/18/2014)... Dallas, Texas (PRWEB) August 19, 2014 ... China Linalool Industryā€¯ is a professional and in-depth ... report provides basic Linalool information, including its ... well as industry overview. This research covers the ... well as global industry analysis covering macroeconomic environment ...
Breaking Biology Technology:Global Solid Oxide Fuel Cells (SOFCs) - Strategic Business Report 2014 2Global Spectroscopy Equipment and Accessories - Strategic Business Report 2014 2Synthetic Biologics Announces Late-Breaking Poster Presentation for C. difficile Program at 54th ICAAC 2Synthetic Biologics Announces Late-Breaking Poster Presentation for C. difficile Program at 54th ICAAC 3Synthetic Biologics Announces Late-Breaking Poster Presentation for C. difficile Program at 54th ICAAC 4Linalool Industry & Diphenylamine Market (Global, China) 2014 Analysis Now Available at DeepResearchReports.com 2Linalool Industry & Diphenylamine Market (Global, China) 2014 Analysis Now Available at DeepResearchReports.com 3Linalool Industry & Diphenylamine Market (Global, China) 2014 Analysis Now Available at DeepResearchReports.com 4
... ALTO, Calif., July 16 Jazz,Pharmaceuticals, Inc. (Nasdaq: ... entered,into definitive agreements with selected investors to sell ... (i) one share of the Company,s,common stock, par ... a,warrant to purchase 0.45 of a share of ...
... PRINCETON, N.J., July 16 BioWa, Inc. ... today that they have entered into a,license ... ever access to,BioWa,s COMPLEGENT(TM) Technology for enhancing ... antibodies., The license grants Medarex non-exclusive ...
... July 16 ,Simbionix, eLearning division, eTrinsic, announced ... Learning Management System (LMS), incorporating the,True Assessment ... LMS already delivers state-of-the-art online medical,education modules ... V6.0 adds enhanced administration and reporting functions ...
Cached Biology Technology:Jazz Pharmaceuticals Announces $26.0 Million Registered Direct Offering 2Jazz Pharmaceuticals Announces $26.0 Million Registered Direct Offering 3BioWa and Medarex Announce License of BioWa's COMPLEGENT(TM) Technology 2BioWa and Medarex Announce License of BioWa's COMPLEGENT(TM) Technology 3BioWa and Medarex Announce License of BioWa's COMPLEGENT(TM) Technology 4Simbionix Releases Powerful New Learning Management System With Enhanced True Assessment System(TM) 2
(Date:8/19/2014)... must be made to decrease China,s increasing caesarean section ... in BJOG: An International Journal of Obstetrics and ... highest caesarean delivery rates in the world. Of 16 ... caesarean. Although the exact rate is not known, the ... reports total caesarean rates ranging from 36% to 58%. ...
(Date:8/19/2014)... a monkey. It,s not a lemur. It,s not an African ... tarsier: a tiny, adorable and downright "cool" primate from Southeast ... are familiar with," said Rafe Brown, curator-in-charge at the University ... ears; an extremely cute, furry body; a long tail with ... and toe tips that look a bit like the disks ...
(Date:8/19/2014)... neonatal abstinence syndrome (NAS) secondary to in-utero opioid ... withdrawal than others, but the underlying reasons are ... genes are turned on or off) changes have ... Boston University School of Medicine (BUSM) and Boston ... kind study to identify some of these epigenetic ...
Breaking Biology News(10 mins):Is China's 50 percent cesarean section delivery rate too high? 2Is China's 50 percent cesarean section delivery rate too high? 3Philippine tarsier gets boost from Kansas research, and genetic proof of a new variety 2Philippine tarsier gets boost from Kansas research, and genetic proof of a new variety 3In-utero methadone, Subutex exposure could alter gene expression, cause severe Neonatal Abstience Syndrome 2
... Eleutherodactylus audanti , from ,Massif de la Selle. ... Caribbean islands, including the coqui frogs of Puerto Rico, originated ... voyage from South America about 30-to-50-million years ago, according to ... which will be published in the 12 June 2007 issue ...
... eggs, ovarian tissue, blood vessels, even whole organs available ... are directly comparing slow-freezing techniques, used successfully for decades ... method of cryopreservation that transforms tissues into durable glass-like ... the Medical College of Georgia are comparing the two ...
... of the length of nectar spurs--the long tubes leading ... to match the tongue lengths of the pollinators that ... were Justen Whittall of the University of California at ... at Santa Barbara. They were funded by the National ...
Cached Biology News:Caribbean frogs started with a single, ancient voyage on a raft from South America 2Caribbean frogs started with a single, ancient voyage on a raft from South America 3Caribbean frogs started with a single, ancient voyage on a raft from South America 4Studies to find better ways to preserve human eggs, ovarian tissue under way 2Studies to find better ways to preserve human eggs, ovarian tissue under way 3Studies to find better ways to preserve human eggs, ovarian tissue under way 4Studies to find better ways to preserve human eggs, ovarian tissue under way 5Columbine flowers develop long nectar spurs in response to pollinators 2
... globigii 5'GCCNNNN NGGC3' 3'CGGN NNNNCCG5' Inactivation Conditions: ... or phenol treatment followed by ethanol precipitation. ... KCl, 0.1mM EDTA, 1.0mM DTT, 0.01% BSA, ... dry ice. Store at -20C. Unit Definition: ...
...
Anti-Tissue Trans-glutaminase (IgA) EIA Sample Size: 10 l...
... EnzChek Lysozyme Assay Kit (E-22013) provides,researchers ... levels of lysozyme,activity in solution. This ... to 20 U/mL (Figure 1). The ... cell,walls, which are labeled to such ...
Biology Products: