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:8/28/2014)... 28, 2014  Next month, executives from clinical trial marketing ... events beginning with Patient-Centered Clinical Trials 2014 , to ... Boston , September 4-5. Patient recruitment experts Bonnie ... Fleishman will share insights on the benefits of employing ... tactics – from media to mobile apps – can be ...
(Date:8/28/2014)... Sterlitech is proud to announce that ... stable of products . These additional products ... include membrane filters with surface charges. , ... for our membrane process testing equipment, and correspondingly, a ... membranes,” explains Sterlitech President Mark Spatz. “The addition ...
(Date:8/28/2014)... Exciting new work by a Florida State University research ... can take your temperature, emit white light, and convert ... molecule looks like a butterfly. , Biwu Ma, associate ... in the FAMU-FSU College of Engineering, created the molecule ... continued to discover that his creation has many other ...
(Date:8/28/2014)... Vt. (PRWEB) August 28, 2014 ... testing around the world is available from Strategic ... diagnostics companies. “ Industrial Microbiology Market Review, Fourth ... Industrial Market ” (IMMR—4) tracks and compares microbiology ... in North America, Europe and Asia, and forecasts ...
Breaking Biology Technology:BBK Worldwide Leads Sessions at Key September Events 2Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 2Novel 'butterfly' molecule could build new sensors, photoenergy conversion devices 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 3
... 29 Cadence Pharmaceuticals,Inc. (Nasdaq: CADX ... and commercializing proprietary product candidates principally,for use ... the company,s,President and CEO Theodore Schroeder will ... 6 at 1:30pm Eastern Time (10:30am Pacific ...
... U.S. Attorney,s, Office for Eastern District of Pennsylvania and ... Settles State Cases with Connecticut and ... (Nasdaq:,CEPH) announced today it has finalized a previously announced ... Eastern District of,Pennsylvania, the U.S. Department of Justice and ...
... Calif., Sept. 29 Poniard,Pharmaceuticals, Inc. (Nasdaq: PARD ... Jerry McMahon, Ph.D., chairman and CEO,will present at the ... 9 a.m. Eastern Time at Le Parker Meridien in ... overview, including a discussion,of the development of picoplatin, the ...
Cached Biology Technology:Cadence Pharmaceuticals' CEO Theodore Schroeder to Present at the JMP Securities Third Annual Healthcare Focus Conference 2Cephalon Concludes All Outstanding Federal and State Government Investigations into the Company's Sales and Promotional Practices 2Cephalon Concludes All Outstanding Federal and State Government Investigations into the Company's Sales and Promotional Practices 3Cephalon Concludes All Outstanding Federal and State Government Investigations into the Company's Sales and Promotional Practices 4Poniard Pharmaceuticals to Present at the JMP Securities Healthcare Focus Conference 2
(Date:9/1/2014)... 1, 2014, 10:20 AM EDT) It may be ... foods over unhealthy higher-calorie foods, according to new research ... Research Center on Aging (USDA HNRCA) at Tufts University ... the journal Nutrition & Diabetes , a brain ... it is possible to reverse the addictive power of ...
(Date:9/1/2014)... ago, electron microscopy revealed the presence of tiny blob-like ... But scientists still don,t know what they do ... believed to be crucial to the life of a ... disease treatment., In the Journal of Cell Biology ... from various backgrounds, from biophysics to cell biology, to ...
(Date:9/1/2014)... Section of the XVIII International Botanical Congress took place ... held every six years and it is where the ... fungi and plants get together to debate and update ... This is the primary product of the meeting, the ... which was published in 2012. The other important product ...
Breaking Biology News(10 mins):Training your brain to prefer healthy foods 2Scientists call for investigation of mysterious cloud-like collections in cells 2Week-long meeting on naming algae, fungi, and plants recorded for posterity 2
... Works to Strengthen Security for Anyone with ... Sept. 17 Today a,Southwest Airlines pilot ... be screened by,the Transportation Security Administration (TSA) ... demonstration project called,SecureScreen will utilize biometrics to ...
... $24 million in federal funding to establish the University ... CEIN), which will help researchers design safer and more ... to be housed at the California NanoSystems Institute (CNSI) ... nanomaterials on life forms and the interactions of these ...
... Foundation (NSF) and the Environmental Protection Agency (EPA) have ... Implications of NanoTechnology (CEINT) to explore the potential ecological ... as a million times smaller than the head of ... objects made from the same material. These unusual properties ...
Cached Biology News:Southwest Pilots Launch TSA Demonstration Project to Test Biometric Screening 2UCLA, partners establish new center on environmental effects of nanotechnology 2UCLA, partners establish new center on environmental effects of nanotechnology 3UCLA, partners establish new center on environmental effects of nanotechnology 4Duke to lead new NSF, EPA center to study the environmental implications of nanotechnology 2Duke to lead new NSF, EPA center to study the environmental implications of nanotechnology 3
Whole blood is collected from healthy pigs (mixed breed, either sex) at the time of slaughter, refrigerated within 6 hours, processed within 24 hours and frozen at -20ºC....
ANTI S. ENT TOX BC2D...
Human/Mouse/Rat Keap1 MAb (Clone 333116) Protein Family: Transcription Factor Regulators...
Reacts with MBP from human, bovine and rat, epitope 129-138. Reacts weakly with rabbit. Does not react with guinea pig....
Biology Products: