Navigation Links
Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency
Date:1/12/2011

INDIANAPOLIS, Jan. 12, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted today to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).

During the meeting, the committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.  

"We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application," said Eiry Roberts, M.D., Vice President, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly. "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."

The FDA is not required to follow the recommendation of its advisory committees.

About Liprotamase & Pancreatic Enzyme Replacement Therapy

Liprotamase is an oral, non-porcine, pancreatic enzyme replacement therapy (PERT) under FDA review for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and pancreatectomy. PERT is a treatment involving the oral administration of pancreatic enzyme replacements, which include protease, amylase and lipase.

Patients with EPI cannot properly digest and absorb nutrients including fat, protein and carbohydrates. Causes of EPI include cystic fibrosis (a life-threatening genetic disorder), chronic pancreatitis and pancreatectomy (surgical removal of the pancreas).

Cystic fibrosis affects approximately 30,000 children and adults in the United States and
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
2. Statement From The National Conclave on HIV/AIDS Policy for Black Clergy
3. Statement by US Oncology on FDA Label on Erythropoiesis Stimulating Agents (ESAs)
4. AIDS Action Council Statement on World AIDS Day 2007: Leadership Needed for a National Strategy to Stop the AIDS Epidemic
5. Statement of Andrea Kavanagh, Director, Pure Salmon Campaign, on the Science Sea Lice Study
6. Statement from the American Diabetes Association Related to ACCORD Trial Announcement
7. Media Statement: MHA Keystone Center for Patient Safety & Quality OHRP Ruling
8. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
11. VA Statement on Smoking Cessation Research Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/21/2015)... April 21, 2015 Cardiologists at Henry Ford Hospital ... in patients with an irregular heartbeat. With only ... Henry Ford is able to add another option to ... which affects the heart,s ability to pump. ... and first-ever commercial Watchman implant at a non-clinical trial site," ...
(Date:4/21/2015)... 2015  St. Vincent Healthcare is raising the ... following strict disinfection routines, St. Vincent Healthcare is now ... harmful germs, like Ebola, methicillin-resistant Staphylococcus aureus ... infect patients during their hospital stay. ... - http://photos.prnewswire.com/prnh/20150420/199749LOGO ...
(Date:4/21/2015)... YORK , April 21, 2015  IntelliQuit™, the world,s first smartphone breathalyzer for smokers, was ... Forum in New York City on Wednesday April 22.  ... ... ... Thirty percent (30%) of all ...
Breaking Medicine Technology:Stroke Risk Caused by Abnormal Heart Rhythm Reduced Without Blood Thinners 2Stroke Risk Caused by Abnormal Heart Rhythm Reduced Without Blood Thinners 3St. Vincent Healthcare Deploys Germ-Killing Robot to Prevent Infection, Protect Patients During Hospital Visits 2St. Vincent Healthcare Deploys Germ-Killing Robot to Prevent Infection, Protect Patients During Hospital Visits 3IntelliQuit World's First Smartphone Breathalyzer for Smokers to Present to American Heart Association Innovation Investment Forum 2IntelliQuit World's First Smartphone Breathalyzer for Smokers to Present to American Heart Association Innovation Investment Forum 3
(Date:4/21/2015)... 21, 2015 Respected academic institution selects ... , Visage Imaging Inc. (“Visage”), a wholly owned ... signed a seven-year contract with University of Florida Health ... The deal furthers the penetration of Visage ... key area of the North American enterprise imaging market. ...
(Date:4/21/2015)... Chicago, IL (PRWEB) April 21, 2015 ... the online retailer known for innovation at its healthiest, ... supplements starting May 1st. , At Wojo Nutrition, they’ve ... health seekers with convenient solutions tailored to meet their ... designed to be blended with any beverage, has been ...
(Date:4/21/2015)... Now in its fifteenth year, the ... unite over 3,000 senior attendees from across the ... Collection Showplace on June 3 and 4. This ... and Kia are set to deliver headline and ... reshaping automotive as connectivity paves the way towards ...
(Date:4/21/2015)... 21, 2015 Carinsuranceshoppingsource.com has released ... comprehensive auto insurance plans . , Comprehensive ... coverage for numerous situations. The coverage limit can also ... auto insurance will protect a car against fire damage, ... Comparing quotes is no longer difficult and it can ...
(Date:4/21/2015)... According to a recent article published ... Wolf has made naloxone available for anyone to have ... a pharmacy without a doctor’s order- in an attempt ... addiction. Pennsylvania’s state police will also begin carrying naloxone ... Narcan) is an opiate overdose reversal medication. The medicine ...
Breaking Medicine News(10 mins):Health News:Visage Imaging Signs University of Florida Health 2Health News:Visage Imaging Signs University of Florida Health 3Health News:Visage Imaging Signs University of Florida Health 4Health News:Wojo Nutrition Announces their Lines of Single Serving Liquid Vitamins will be Available for Purchase online at Abesmarket.com Beginning in May 2Health News:TU-Automotive Detroit 2015 Sample Attendee List Released 2Health News:TU-Automotive Detroit 2015 Sample Attendee List Released 3Health News:Comprehensive Auto Insurance Is An Important But Complex Policy 2Health News:Drug Rehab Philadelphia Comments on Gov. Wolf’s Decision to Make Naloxone Widely Available 2
... by many, because of its omega-3 fatty acids and, ... of farmed (mostly Atlantic salmon) and wild salmon fish// ... salmon, are contaminated with more environmental pollutants such as ... from Alaska. Many consumers have a choice between farm-raised ...
... hepatitis C virus infection is a bad prognostic ... renal transplant recipients//. ,Hepatitis C virus (HCV) infection ... the prevalence depends on the geographic area. Infections ... transplant recipients. ,Researchers from the Armed Forces ...
... British Indian psychiatrist apparently has plagiarised the work of ... his own in an article for a medical journal//. ... edition was written by Raj Persaud and went unnoticed ... Persaud is one of the youngest doctors to become ...
... Canadians are rushing to India and other Asian countries ... waiting//. ,According to a recent report, Canada is ... for three years for procedures such as knee replacement and ... now turning to the World Wide Web to find medical ...
... initiative for Center for Clinical Global Health Education was ... that improvement of medical care to patients would improve ... better way//, his initiative was to provide training by ... distance learning for healthcare providers. Bollinger said, “Don’t wait ...
... pre-eclampsia, the level of maternal serum leptin is increased ... TNF-á//. ,The research was conducted at University ... serum leptin concentration in women with pre-eclampsia and women ... leptin and several inflammatory cytokines. ,The study appears ...
Cached Medicine News:Health News:Indian Psychiatrist in UK Accused of plagiarism 2Health News:Indian Psychiatrist in UK Accused of plagiarism 3Health News:John Hopkins CGHH program provides Global Health education 2
Inquire...
The autoclavable, aluminum needle box is designed to store loaded needles and help protect personnel from exposure. Each shield consists of an aluminum box with faceplate to match the grid pattern th...
... Brachytherapy loaders allow for efficient, easy ... Connectors to your customized plans at ... Bard loaders is the flexibility to ... in the QuickLoad™ Loader allows for ...
... designed to help you achieve one important ... procedure. All needles are engineered for exceptional ... for smooth entry and exit. A broad ... an ideal match with procedural needs and ...
Medicine Products: