NovoNordisk released information today saying that the FDA has put off formal considerations for the new diabetes drug, liraglutide, for a few more months. It doesn't seem that Novo is bothered by this decision as they have a lot of confidence in this drug that already has European approval. Liraglutide has an interesting mechanism of action that looks to only stimulate the release of insulin when glucose levels are high, thus decreasing the likelihood of dangerous fluctuations in blood sugar levels. As an added bonus, the medication also seems to suppress appetites and may have weight loss properties (presumably). For more information see the following articles:
Reuters
Previous Study Results
NovoNordisk
Watch and wait for now, but this does not look like a situation where the FDA will drop the hammer on the NDA...rather it seems like a standard example of regulatory red tape slowing things down.
New NovoNordisk drug on hold
23 September 2009 |
Posted by
E
Labels:
clinical hold,
FDA,
liraglutide,
NDA,
NovoNordisk
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