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 laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about liprotamase for the treatment of exocrine pancreatic insufficiency (EPI). It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that liprotamase will be approved by the FDA on the anticipated timeline or at all, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The companies undertake no duty to update forward-looking statements.

P-LLY

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO)


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

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:5/26/2017)... , May 26, 2017  Endo International plc (NASDAQ: ... President and CEO, will represent the Company in a fireside ... Conference on Tuesday, June 13, 2017 at 10:40 a.m. PT ... Terranea Resort in Rancho Palos Verdes, CA. ... the event will be available on the Company,s website at ...
(Date:5/22/2017)... 22, 2017  Lilac Corp, the company that ... launch of a new website . The ... a clinical study that showed surprising clearance of ... in individuals suffering from HPV warts, precancerous, or ... are no other treatments that clear the virus. ...
(Date:5/15/2017)... , May 15, 2017  Amy Baxter MD, ... industry leader in noninvasive pain relief, was awarded a ... magazine. Baxter was recognized at the MM&M Top ... New York City on May 10, 2017. ... the biopharma industry go "beyond the pill."  ...
Breaking Medicine Technology:
(Date:5/29/2017)... ... 2017 , ... The quest to develop a cure for HIV has long ... cured? The virus has a knack for lying dormant in immune cells at levels ... University of Pittsburgh’s Graduate School of Public Health announced today in Nature Medicine that ...
(Date:5/28/2017)... ... May 28, 2017 , ... Florida Pain Relief Group, a ... K. Cho, MD, has joined its Winter Haven practice. , Dr. Cho’s ... invasive techniques to treat and manage many types of pain. , Dr. ...
(Date:5/27/2017)... ... May 27, 2017 , ... In any business, follow up is critical to ... dental team at presenting treatment, there will always be some patients who can’t or ... money on best practices when it comes to presenting treatment. After the patient ...
(Date:5/26/2017)... ... 26, 2017 , ... The American Parkinson Disease Association’s ... grant submissions all vying for nearly $1,000,000 in funding that will be awarded ... American Parkinson Disease Association (APDA) is focused on advancing scientific research that will ...
(Date:5/26/2017)... Calif. (PRWEB) , ... May 26, 2017 , ... ... the integration of the CareFusion NOX-T3 portable sleep monitor with its Somnoware Sleep ... a consistent, browser-based interface for diagnostic device operations. With this platform, initializing devices ...
Breaking Medicine News(10 mins):