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:9/27/2017)... CAESAREA, Israel and NEW YORK , Sept. ... company with mobile health and big data solutions, today announced that its ... today. Please check your local TV listings for when The Dr. Oz ... ... ninth season this month. ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy that ... developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led R&D and ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Yisrayl Hawkins, ... week that explains one of the most popular and least understood books in the ... cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed it ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian ... On The Brink” is the creation of published author, William Nowers. Captain Nowers ... a WWII veteran, he spent thirty years in the Navy. Following his career ...
Breaking Medicine News(10 mins):