Navigation Links
Lilly Receives Complete Response Letter From FDA for Liprotamase for the Treatment of Exocrine Pancreatic Insufficiency
Date:4/15/2011

INDIANAPOLIS, April 15, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), under investigation for the treatment of exocrine pancreatic insufficiency (EPI).

The complete response letter communicated the need for Lilly to conduct an additional clinical trial prior to a re-submission.

"Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible," said Eiry Roberts, M.D., Vice President, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly.  "We are committed to working with the Agency and the cystic fibrosis community to make this important treatment option available to patients."

People with EPI have very low levels or none of the key digestive enzymes made by the pancreas - lipase, amylase and protease - in their small intestine, resulting in improper digestion and absorption of fat, carbohydrates and proteins, often requiring treatment with PERTs. EPI occurs very frequently in patients with cystic fibrosis (a life-threatening genetic disorder) and in other diseases including chronic pancreatitis and pancreatectomy.

About Liprotamase

Liprotamase is an oral, non-porcine (not made from harvesting the pancreas of pigs), biotechnology-derived, pancreatic enzyme replacement therapy (PERT) developed to treat patients with EPI associated with cystic fibrosis, chronic pancreatitis and pancreatectomy.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laborator
'/>"/>

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

Page: 1 2

Related medicine technology :

1. Avant Healthcare Marketing Receives 2010 Lilly Global Sustained Supplier Award
2. Lilly Confirms Date and Conference Call for First-Quarter 2011 Financial Results Announcement
3. Two Novel Lilly Molecules Target Genetic Mutations That Can Lead to Cancer
4. Lillys Connecting Hearts Abroad Program Sends Employees on Global Service Assignments
5. Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection)
6. NAFE Names Lilly to Top 50 Companies for Executive Women
7. Lilly Makes an Irrevocable Offer to Acquire Janssen Animal Health
8. Lilly Announces New Vice President of Oncology Research
9. Lilly CEO Calls for Biopharmaceutical Industry Changes and Policies That Encourage Medical Innovation
10. Lilly Marks Major Milestone for Mirror Portfolio with Agreement by Independent Fund to License First Two Investigational Medicines
11. Lilly Announces Senior Leadership Changes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)...  ArmaGen, Inc., a privately held biotechnology company ... neurological disorders, announced today that the first patient ... clinical trial of AGT-181 in patients with attenuated ... AGT-181 is an investigational enzyme replacement therapy (ERT) ... severe form of MPS I, Hurler syndrome, is ...
(Date:9/2/2015)... , Sept. 2, 2015 Unilife Corporation ("Unilife" ... UNS), a developer, manufacturer and supplier of injectable drug ... initiated expressions of interest, the Company,s Board of Directors ... a review of strategic alternatives to maximize shareholder value. ... and evaluated during the review process may include a ...
(Date:9/2/2015)... September 2, 2015 According to ... Product (Digital & Computed Radiography, Ultrasound, Computed & Optical ... by Application (Oncology, Cardiology, Neurology) - Global Forecast to ... reach USD 2.8 Billion by 2020 growing at a ... Br owse 240 Tables and 44 F ...
Breaking Medicine Technology:ArmaGen Announces First Patient Dosed in Phase 1/2a Clinical Trial of AGT-181 for the Treatment of Hurler Syndrome 2ArmaGen Announces First Patient Dosed in Phase 1/2a Clinical Trial of AGT-181 for the Treatment of Hurler Syndrome 3ArmaGen Announces First Patient Dosed in Phase 1/2a Clinical Trial of AGT-181 for the Treatment of Hurler Syndrome 4Unilife Announces Review of Strategic Alternatives 2Veterinary Imaging Market Worth USD 2.8 Billion by 2020 2Veterinary Imaging Market Worth USD 2.8 Billion by 2020 3Veterinary Imaging Market Worth USD 2.8 Billion by 2020 4Veterinary Imaging Market Worth USD 2.8 Billion by 2020 5
... , NEW YORK, Nov. 24 A FOX ... viewers that the holidays are a time to be grateful for ... who fight that battle each day as survivors, caregivers, and advocates. ... ice of cancer survivors Scott Hamilton and Dorothy Hamill and a ...
... , SAN MATEO, Calif., Nov. 24 NeurogesX, ... developing and commercializing novel pain management therapies, today announced the ... effective November 19, 2009. Mr. Orwin is a 20-year sales ... instrumental in the launch of several important therapeutics. , Mr. ...
Cached Medicine Technology:FOX Thanksgiving Day Special 'Kaleidoscope' Unites Cancer Survivors on Ice and in Song to Celebrate Survivorship 2FOX Thanksgiving Day Special 'Kaleidoscope' Unites Cancer Survivors on Ice and in Song to Celebrate Survivorship 3NeurogesX Appoints Seasoned Sales and Marketing Executive as New Board Director 2NeurogesX Appoints Seasoned Sales and Marketing Executive as New Board Director 3NeurogesX Appoints Seasoned Sales and Marketing Executive as New Board Director 4
(Date:9/2/2015)... ... ... The medical waste management market is expected to reach USD 13.3 billion ... global medical waste management market is segmented based on type of waste, services, treatment ... the highest growth rate in the medical waste management market, by service, during the ...
(Date:9/2/2015)... , ... September 02, 2015 , ... ... combining both naturopathic and allopathic medicine, opens its second location this week at ... features roughly 1000 square feet of lounge space for patients to relax while ...
(Date:9/2/2015)... ... September 02, 2015 , ... Every year at this time, students prepare ... few are prepared to face the academic workload confronting them. They just don’t have ... them since schools don’t teach students how to study. , “Bankers bank. Salesmen sell. ...
(Date:9/2/2015)... & Minneapolis, MN (PRWEB) , ... September 02, ... ... that is commercializing products for the upper extremity surgical market, announced today that ... surgical instrument for trigger releases in the hand. Plus, nearly 70 of ...
(Date:9/2/2015)... ... September 02, 2015 , ... ... to bring awareness to International Overdose Awareness Day. The goal is to provide ... the warning signs so that they may get help. , Lakeview ...
Breaking Medicine News(10 mins):Health News:Medical Waste Management Market Growing at 5.2% CAGR to 2020 2Health News:Medical Waste Management Market Growing at 5.2% CAGR to 2020 3Health News:Medical Waste Management Market Growing at 5.2% CAGR to 2020 4Health News:Medical Waste Management Market Growing at 5.2% CAGR to 2020 5Health News:The Hydration Room Opens New Location In Laguna Beach, California 2Health News:The Hydration Room Opens New Location In Laguna Beach, California 3Health News:The Hydration Room Opens New Location In Laguna Beach, California 4Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 2Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 3Health News:Trigger Tome Surpasses 600 Successful Patient Procedures 2Health News:August 31 is International Overdose Awareness Day – Lakeview Health to Help Bring Awareness 2
... Checks Eligibility for Medicaid, Child Health Plus, Family Health PlusTARRYTOWN, ... www.EnrollNY.org -- allows uninsured ... and -- for the first time -- connects users to ... to residents of New York City,s five boroughs and six ...
... May 7 Eclipsemed Ltd, a leading national ... AG, of Germany, a leading manufacturer of medical and aesthetic ... will be featured on the Lifetime Network,s The ... targeting women and women,s issues. The program will air on ...
... in First Quarter ResultsHARRISBURG, Pa., May 7 ... its 2009 community outreach program has provided more ... underserved in the first quarter of 2009."The tough ... for the uninsured community to seek the proper ...
... Neuromodulation , edited by Elliot S. Krames, P. ... is the first comprehensive and in-depth reference textbook covering ... by providing a complete discussion of the fundamental principles ... cord, peripheral nerves, autonomic nerves and various organs. The ...
... the FRAX Slide-kit, has been launched by the ... World Health Organization Collaborating Centre for Metabolic Bone ... can be downloaded free of charge from the ... The FRAX Slide-kit is intended as a teaching ...
... of the condition may decrease potential riskSCHAUMBURG, Ill., May ... as hyperhidrosis already have to deal with a number ... stains can make simple tasks such as shaking hands ... new study, people with primary hyperhidrosis also have a ...
Cached Medicine News:Health News:EnrollNY(TM): Easy Way for Uninsured New Yorkers to Find Free and Low-Cost Health Insurance 2Health News:Body-Jet(R), State of the Art Water-Jet Assisted Liposuction Technology to be Featured on Lifetime Television Network, The Balancing Act 2Health News:United Concordia Provides $100,000 in Free Dental Services 2Health News:Study Finds That Patients With Excessive Sweating Condition Are More Likely to Develop Skin Infections 2Health News:Study Finds That Patients With Excessive Sweating Condition Are More Likely to Develop Skin Infections 3
Fenestrated 14 mm blades and canthus bar. Adjustable blade locking screws on outside of branches. Dull finish....
Double bent ends prevent wire from catching when pushed forward. Designed for use with the Castroviejo Snare (E3675). Package of 12 stainless steel wires. Overall length 4.3 inches....
Replacement snares for the E3525. 3 per package....
... to be used only with the E3671 twisted ... turning the wing nut and the loop can ... by ratchet so that the loop can be ... Overall length - 5.6 inches. Comes with one ...
Medicine Products: