Navigation Links
Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy
Date:12/20/2010

SAN DIEGO, Dec. 20, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that it has submitted the initial sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy. Consistent with the severity and rare nature of the disorder, Amylin has received both orphan drug designation from FDA's Office of Orphan Products Development, as well as Fast Track designation for the use of metreleptin in patients with lipodystrophy. The focus of this marketing application is on rare inherited and acquired forms of lipodystrophy.

In the first part of its rolling submission, the Company submitted the nonclinical and clinical sections of the BLA. The Company plans to submit the chemistry, manufacturing and controls (CMC) section of the BLA by the end of 2011, which will complete the submission.

"It is gratifying to see that, after years of research focused on leptin as an effective therapy for lipodystrophy, we are now closer to bringing this important and innovative medicine to patients who are in dire need of better treatments," said Phillip Gorden, M.D., Director Emeritus, Senior Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Dr. Gorden is the principal investigator of an ongoing NIH clinical study evaluating the long-term efficacy of metreleptin treatment in lipodystrophy.

Lipodystrophy syndromes are characterized by abnormalities in adipose (fat) tissue distribution with loss of subcutaneous fat, and often manifest in childhood or adolescence. Patients with lipodystrophy can have multiple severe metabolic abnormalities, includin
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity
2. Amylin Pharmaceuticals to Present Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Society
3. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
4. Amylin Pharmaceuticals Highlights New Data Supporting Therapeutic Potential of Obesity Pipeline at Obesity 2009
5. Amylin Pharmaceuticals Reports Third Quarter Financial Results
6. Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDAs BYETTA(R) (Exenatide) Injection Update
7. Amylin Pharmaceuticals to Present at the 18th Annual Credit Suisse Healthcare Conference
8. Amylin Pharmaceuticals to Webcast Year-End Financial Results
9. Amylin Highlights 2010 Corporate Priorities at J.P. Morgan Healthcare Conference
10. Amylin and Takeda Announce Decision to Advance Development of Pramlintide/Metreleptin Combination Treatment for Obesity
11. Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)...  Hologic, Inc. (NASDAQ: HOLX ), today ... Chief Executive Officer, will preside over the NASDAQ Stock ... day of Breast Cancer Awareness Month. In his remarks, ... the important benefits of Hologic,s 3D Mammography technology, the ... superior to traditional mammography. This is the ...
(Date:9/30/2014)... , Sept. 30, 2014 This ... for molecular imaging informatics solutions including nuclear imaging ... and comparison. The study assesses the size of ... 2010 and 2013, and projects future growth based ... as the dynamics taking place in the broader ...
(Date:9/30/2014)... 30, 2014 Aileron Therapeutics, Inc. - ... Global Markets Direct,s, ,Aileron Therapeutics, Inc. - Product ... the Aileron Therapeutics, Inc.,s pharmaceutical research and development ... the current therapeutic developmental pipeline of Aileron Therapeutics, ... therapeutics assessment by drug target, mechanism of action ...
Breaking Medicine Technology:Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 3Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3Aileron Therapeutics, Inc. - Product Pipeline Review - 2014 2Aileron Therapeutics, Inc. - Product Pipeline Review - 2014 3
... , STAMFORD, Conn., Nov. 13 ... will be releasing a free trial version of its Zargis ... conference, taking place this November 15-17 in Orlando. Zargis is ... the companion hardware -- the 3M Littmann Electronic Stethoscope Model ...
... BERWYN, Pa., Nov. 13 /PRNewswire-FirstCall/ -- Encorium Group, ... multinational clinical research organization (CRO) conducting studies in over ... and biotechnology companies, today announced that it has appointed ... 7, 2009. Ms. Laitinen, age 43, will replace ...
Cached Medicine Technology:Zargis to Release Trial Version of Cardioscan while Exhibiting with 3M(TM) Littmann(R) at American Heart Association Conference 2Zargis to Release Trial Version of Cardioscan while Exhibiting with 3M(TM) Littmann(R) at American Heart Association Conference 3Encorium Group, Inc. Appoints Sari Laitinen to Board of Directors 2Encorium Group, Inc. Appoints Sari Laitinen to Board of Directors 3
(Date:10/1/2014)... research suggests the adage that encourages people to keep ... when it comes to exercise. When walking, staying focused ... to it appear shorter and help people walk there ... this technique to walking while looking around the environment ... of exercise. , "People are less interested in exercise ...
(Date:10/1/2014)... October 01, 2014 Lifeinsurance-policy.com has ... the best life insurance prices for smokers. , Smoking ... insurance premiums. Comparing quotes is the best method to ... quotes for customers who need coverage. , Whole ... duration of the policy. Since the coverage is permanent, ...
(Date:10/1/2014)... Join the more than 80 golfers who already have ... charity golf tournament to benefit Project HEAL, a not-for-profit organization ... afford treatment. The tournament will be held Monday, Oct. 6, ... The day-long event starts with 10:30 a.m. check-in and shotgun ... begin at 5 p.m. and will include an auction featuring ...
(Date:10/1/2014)... City, NJ (PRWEB) October 01, 2014 Diet ... with their intentions to lose weight and their dieting attempts ... unhealthy, fatty foods. Including hormone diet treatments into ... only allows patients to see fast and effective weight loss ... and begin forming healthy habits to maintain their weight for ...
(Date:10/1/2014)... occasion of the Leishmaniasis East Africa Platform meeting, ... leishmaniasis experts, results of a pharmacovigilance or ... carried out by MSF, DNDi, and national partners ... to key decision makers in order to boost ... combination of Sodium Stibogluconate and Paromomycin (SSG&PM) in ...
Breaking Medicine News(10 mins):Health News:Keeping your eyes on the prize can help with exercise, NYU study finds 2Health News:Keeping your eyes on the prize can help with exercise, NYU study finds 3Health News:Affordable Whole Life Insurance Premiums for Smokers! 2Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 2Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 3Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 2Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 3Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 4Health News:Results of large-scale roll out of combination treatment for kala-azar in Eastern Africa 2
... ... of MD Anderson will be conducting a lecture on Radiation Therapy Options for Mesothelioma patients. ... ... -- Mesothelioma lecture on Tuesday November 10th, 2009, 5:30 pm CST, MesoCare.org is ...
... ... collaborating to provide Davis Applied Technology College with a working showroom of CNC machines. ... Okuma open-architecture THINC control. Grand Opening January 12-14, 2010. , ... Charlotte, NC (PRWEB) November 9, 2009 ...
... HUYA Bioscience International, a leader in ... partnership with the School of Medicine and Pharmacy, ... in a series of collaborations that HUYA has ... to enable and accelerate the global development and ...
... Nov. 8 Today, the nation Mayors commended the ... Care for America Act, a historic piece of legislation, ... , In June, at the US Conference of Mayors ... nation unanimously supported the health care reform principles of ...
... finds , SUNDAY, Nov. 8 (HealthDay News) -- Your mother ... up straight: New research suggests that good posture could make ... of us were taught that sitting up straight gives a ... study and a psychology professor at Ohio State University, said ...
... Nov. 7 Tonight the House of Representatives passed ... reform legislation that will ensure every American has access ... The legislation, which cracks down on some of the ... million Americans and cut the deficit by $104 billion ...
Cached Medicine News:Health News:Okuma America Corporation & Hartwig, Inc. to Provide Machines to Davis Applied Technology College for Machine Tool Technology Program 2Health News:HUYA Bioscience International Establishes Strategic Partnership with School of Medicine and Pharmacy, Ocean University of China 2Health News:The Nation's Mayors Commend House Passage of Health Reform Bill 2Health News:Good Posture May Inspire Confidence 2Health News:Democratic National Committee Chairman Tim Kaine Issues Statement Praising the House of Representative's Historic Vote to Pass Health Insurance Reform 2Health News:Democratic National Committee Chairman Tim Kaine Issues Statement Praising the House of Representative's Historic Vote to Pass Health Insurance Reform 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
Medicine Products: