Navigation Links
Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA
Date:2/19/2013

insulin was studied because these medicines target separate components of HbA1c, an important measure of blood glucose control. Lixisenatide has a pronounced PPG-lowering effect, which complements the predominantly fasting plasma glucose (FPG)-lowering effect of basal insulin. For patients treated with basal insulin who have controlled FPG but who, due to the progression of type 2 diabetes, are no longer able to achieve their HbA1c goal, adding lixisenatide, which targets PPG, could be an effective strategy to achieve target glucose control.

Available data from the ongoing ELIXA trial, a cardiovascular outcome (CV) study of lixisenatide in patients at high CV risk (i.e. patients who recently experienced an acute coronary event) were also submitted, as required by the FDA.

Sanofi is preparing to launch lixisenatide in the European Union as of late Q1 2013, under the proprietary name Lyxumia. The proprietary name for lixisenatide in the United States is under consideration.

About lixisenatide
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is also approved in Mexico for th
'/>"/>

SOURCE Sanofi
Copyright©2012 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6

Related medicine technology :

1. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
2. Sanofi US Launches Collaborate Activate Innovation Challenge
3. Sanofi Pasteur to add 2D barcode to six more vaccines
4. Sanofi and Regeneron Announce Publication of Phase 2 Results with LDL Cholesterol-Lowering PCSK9 Antibody in the New England Journal of Medicine
5. Sanofi and Regeneron Announce Patient Enrollment in Cardiovascular Outcomes Trial with Antibody to PCSK9 for Hypercholesterolemia
6. Sanofi and T1D Exchange to Launch Worldwide Study to Investigate Factors for Optimal Care for Young People with Diabetes
7. Sanofi Donates $500,000 to Hurricane Sandy for Immediate and Long-Term Relief Efforts
8. Phase II Trial of Sanofi JAK2 Inhibitor in Myelofibrosis Met Primary Endpoint
9. Sanofi Launches Breakthrough Technology for Cardiovascular and Vascular Surgery Procedures
10. Zacks Bull and Bear of the Day Highlights: Smithfield Foods, Logitech International, Sanofi, Isis Pharmaceuticals and Aegerion Pharmaceuticals
11. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... , May 17, 2013 ... economics and outcomes research also   to   be ... SHPG ), the global specialty biopharmaceutical company, ... poster presentations at the American Psychiatric Association (APA) 166th ... May 18-22. The data being presented represent Shire,s ongoing ...
(Date:5/17/2013)... , Puerto Rico , May 17, 2013 ... and western Puerto Rico , Caribbean Imaging ... Center has improved its radiation therapy capabilities with the acquisition ... Puerto Rico . Versa HD offers clinicians the ... of tumors throughout the body, while also enabling treatment of ...
(Date:5/17/2013)... Genetics, Inc. (NASDAQ: ATOS ), The Breast Health ... Chief Financial Officer & General Counsel, will present at the ... 2013, in New York City at ... is scheduled to begin at 3:30 p.m. EDT and will ... go to www.atossagenetics.com . For more information ...
Breaking Medicine Technology:Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 2Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 3Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 4Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 5Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 6Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 7Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 8Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 9Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 10Puerto Rico's Caribbean Imaging and Radiation Therapy Center Orders Elekta's New Versa HD System for Treatment of Cancer Patients 2Atossa Genetics to Present at the Second Annual Marcum LLP MicroCap Conference 2Atossa Genetics to Present at the Second Annual Marcum LLP MicroCap Conference 3
(Date:5/19/2013)... New York (PRWEB) May 19, 2013 ... a Case Management Conference was recently convened for hundreds ... federal multidistrict litigation now underway in U.S. District Court, ... on the Court’s website on May 14th, the Conference ... It was also reported during the Conference that Defendants ...
(Date:5/19/2013)... Dr. Keith Chertok now provides gum disease ... gums and increase the chance of a healthier smile. ... Procedure (LANAP) not only removes diseased gum tissue in patients, ... bone for dental implants. , LANAP uses a ... can also help stimulate the healthy tissue as well as ...
(Date:5/19/2013)... Yeast infections are common in both men and ... the human body. A new yeast infection treatment product has ... unique method of application to help eliminate over growth of ... to men and women searching for a natural process of ... through food and is stored in the intestines. In small ...
(Date:5/19/2013)... 19, 2013 Passages Malibu, the leading ... has announced this week the launch of a “Sobriety, ... social media channels. “We are always looking for ... and to get feedback regarding sobriety, what’s working for ... co-founder of the Passages Addiction Treatment Centers ...
(Date:5/19/2013)... May 19, 2013 The AMTC team will ... the Columbus Georgia Convention & Trade Center on June 1st. ... attend. AMTC auditions are free of charge. , Actors, Models ... for hundreds of successful artists and grads like Caitlin Kinney ... European Tombolini , Chris Young - on his Liquid Neon ...
Breaking Medicine News(10 mins):Health News:Pradaxa Lawyers at Bernstein Liebhard LLP Report on Recent Status Conference in Federal Pradaxa Litigation 2Health News:Pradaxa Lawyers at Bernstein Liebhard LLP Report on Recent Status Conference in Federal Pradaxa Litigation 3Health News:Berkeley, CA Periodontist, Dr. Keith Chertok Now Treats Gum Disease Patients With Laser Gum Surgery Prior to Placing Dental Implants 2Health News:A Safe & Homeopathic Yeast Infection Relief by Yeastrol Now Available at HealthCareSupplementz.com with Massive Discount 2Health News:Passages Malibu Announces its Sobriety, Health, and Wellness Social Media Survey 2Health News:Passages Malibu Announces its Sobriety, Health, and Wellness Social Media Survey 3Health News:Actors, Models and Talent for Christ Hosting Auditions in Columbus, GA June 1st in Search of Local Talent 2
... venom that the snails inject to immobilize their prey ... strokes, central nervous system disorders and other ills. ,The ... equivalent of a compound in the venom of the ... tropical saltwater. ,The snail-venom research involved 111 patients ...
... to lower tar cigarettes in hopes of continuing with ... consequences of higher tar cigarettes.// ,Non-filter cigarettes make up ... States and United Kingdom. A new study shows the ... who smoke medium-tar cigarettes, low-tar cigarettes, or very-low-tar cigarettes. ...
... to eating infected beef was first reported in the United ... for the degenerative, fatal brain disorder.// ,Charlene is the ... form of mad cow disease, according to the Centers for ... are sure Charlene caught the disease while living in Britain.Charlene ...
... in intensive care units following a major surgery, and ... of about 50 percent and according to researchers it ... seriously ill patients. // ,A recently discovered ... from failing after injury, according to new research.For the ...
... dementia in people with Down syndrome with those seen ... issue of Neurology.,// ,Studies indicate 50 percent ... will eventually develop signs of dementia, and autopsies show ... the brain tangles and plaques commonly associated with Alzheimer's ...
... death, heart attack and repeat procedures .,A recent study ... drug-coated stents on patients.// ,The study included ... who were treated with drug-eluting stents. An additional 450 ... stents. ,Results of the one-year study show ...
Cached Medicine News:Health News:The Human Mad Cow Case 2Health News:Hope for Patients With Kidney Failure 2Health News:Dementia and Down Syndrome 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: