Research Update

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has finalised 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 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 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.

 

On 3 April 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.

 

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 23 May 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 15 July 2008.

 

 

Contacts for further information

 

Company Announcement no 20 / 2009