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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
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SOURCE Novo Nordisk
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