When all else fails, punt.
That’s exactly what happened yesterday when the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meet yesterday to discuss Novo Nordisk’s (NYSE:NVO) GLP-1 drug candidate Liraglutide. In one of the more bizarre panel meetings attended by Diabetic Investor the panel basically decided not to decide leaving it up the full FDA to decide how to proceed.
Before we go any further note that Diabetic Investor has a great deal to say on this meeting and is working on a detailed overview of what happened yesterday and what it means. However we understand that our subscribers are anxious for a review so we have decided to offer some quick comments.
1. Diabetic Investor believes the FDA’s final decision on Liraglutide won’t come for another to six, possibly 12 months.
2. Given there was almost no discussion on pancreatitis it appears the FDA is no longer concerned over this issue which bodes well for the upcoming label change for Byetta.
3. While this lack of action by the panel should not delay Amylin’s (NASDAQ:AMLN) time table for submitting Byetta LAR to the FDA, it does provide a road map for Amylin. It’s almost guaranteed that the FDA will ask the panel to review LAR.
4. It’s also certain that the FDA will require additional post-market studies when Liraglutide receives full approval.
5. Although Diabetic Investor senses that the FDA is not overly comfortable with Liraglutide the drug will receive approval. Frankly there just isn’t enough solid evidence that would justify the FDA NOT approving the drug.
As we said earlier Diabetic Investor is writing a more detailed analysis which will be published either later today or over the weekend. As always Diabetic Investor is available should subscribers have questions.
