Navigation Links
Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
Date:4/2/2009

SILVER SPRING, Md., April 2 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has finalized its discussions of questions related to liraglutide, a once-daily human GLP-1 analogue.

The Advisory Committee voted on questions related to the risk profile of liraglutide.

  • A majority of Advisory Committee members supported that appropriate evidence of cardiovascular safety had been provided to rule out excess cardiovascular risk of liraglutide relative to comparators.
  • While a majority of Advisory Committee members did not find that Novo Nordisk based on the available data had ruled out that the finding of C-cell tumours in rodents was not relevant to humans, the Advisory Committee was split on the FDA question related to whether the available data on C-cell tumours permitted approvability.
  • Finally, the Advisory Committee unanimously supported approvability of liraglutide with regard to risk of papillary thyroid cancer.

"We remain convinced that liraglutide has a positive benefit/risk profile and represents an important advance for people with type 2 diabetes. We will work closely with the FDA as it completes its review of our application to address the concerns expressed by members of the Advisory Committee," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

The Advisory Committee reviewed data from 40 clinical studies involving more than 6,800 people with type 2 diabetes of which more than 4,600 were treated with liraglutide.

The timing of US launch of liraglutide will be determined after completion of the FDA's review of the application.

The outcome of the FDA Advisory Committee is not expected to significantly impact Novo Nordisk's expectations for the company's financial results for 2009, which were provided on January 29 in connection with the release of the financial results for 2008. Novo Nordisk will update the expectations for the company's financial results for 2009 on April 30 2009 in connection with the release of the financial results for the first quarter of 2009.

FDA advisory committees are panels of independent experts who advise the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications.

Conference call

On April 3 at 8am CET, corresponding to 2am EDT, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.

About liraglutide

Liraglutide is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. On May 23 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the US as well as a marketing authorisation application to the European Medicines Agency in Europe, for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 15 2008.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 27,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.


'/>"/>
SOURCE Novo Nordisk
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmos Issues Business Update on Dextofisopam Trial and Financing
2. Poniard Pharmaceuticals Reports Fourth Quarter and Year End 2008 Financial Results and Provides a Corporate Update
3. Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Program
4. MannKind Updates Status of NDA Submission for AFRESA
5. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
6. BN ImmunoTherapeutics Updates on Phase I/II Studies With Breast Cancer Vaccine
7. Update of Long-Term Data on Brain Cancer Patients Receiving DCVax(R)-Brain Continues to Show Striking Improvements in Delay of Disease and Survival
8. Savient Provides Update on Pegloticase BLA
9. Synvista Therapeutics Announces Termination of Clinical Trials of Alagebrium and SYI-2074 and Provides Business Update
10. Impact Medical Solutions Announces Appointment of New Director and Corporate Update
11. Clinical Update - Debio 025 in Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... Pa. , June 23, 2016 The ... in an outpatient dialysis facility.  Treatments are usually 3 ... 6 hours per visit, including travel time, equipment preparation ... a patient, but especially grueling for patients who are ... of a skilled nursing and rehabilitation centers for some ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
Breaking Medicine News(10 mins):