ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for monitor Customisable watchlists with full streaming quotes from leading exchanges, such as LSE, NASDAQ, NYSE, AMEX, Bovespa, BIT and more.

NVO Novo Nordisk

144.87
1.20 (0.84%)
After Hours
Last Updated: 00:03:18
Delayed by 15 minutes
Share Name Share Symbol Market Type
Novo Nordisk NYSE:NVO NYSE Common Stock
  Price Change % Change Share Price High Price Low Price Open Price Shares Traded Last Trade
  1.20 0.84% 144.87 145.36 143.43 143.83 2,591,717 00:03:18

Novo Nordisk: FDA Split Over Liraglutide C-Cell Tumour Data

03/04/2009 7:02am

Dow Jones News


Novo Nordisk (NYSE:NVO)
Historical Stock Chart


From Jun 2019 to Jun 2024

Click Here for more Novo Nordisk Charts.
   DOW JONES NEWSWIRES 
 

Novo Nordisk said early Friday that the Endocrinologic and Metabolic Drugs Advisory Committee of the US FDA has finalised its discussions of questions related to liraglutide, its once-daily human GLP-1 analogue.

 
   MAIN FACTS: 
 

- 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.

- 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.

- The 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", says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

- "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".

- 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 29 January 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 30 April 2009 in connection with the release of the financial results for 1Q 2009.

-By Stockholm Bureau, Dow Jones Newswires; +46-8-5451-3090; djnews.stockholm@dowjones.com

 
 
 
 

1 Year Novo Nordisk Chart

1 Year Novo Nordisk Chart

1 Month Novo Nordisk Chart

1 Month Novo Nordisk Chart

Your Recent History

Delayed Upgrade Clock