A strange day
Yesterday was one of the stranger days in the diabetes world, and given what’s been going in the diabetes world that’s saying something. As everyone knows yesterday was the PDUFA date for the long-acting once-a-week version of Byetta, pushed back one week due to the snow storm that hit Washington DC. Based on their recent history Diabetic Investor expected the FDA to wait until after the markets closed to release their decision. Yet instead all we got was news that there were some minor issues at the plant where Byetta LAR is being manufactured; issues that were actually identified long ago and by themselves should not be a major cause for concern.
So there we were along with everyone else in the diabetes world all dressed up and ready but ultimately with nowhere to go.
The first and most obvious question is just what does this mean and frankly Diabetic Investor doesn’t have a clue. Looking at the issues at the manufacturing facility Diabetic Investor does not believe these issues would derail an approval. While this is not a good thing, the issues are being addressed and have nothing to do whether LAR is safe and effective.
While there will be many who see something sinister here Diabetic Investor is not among them. We continue to believe based on all publicly available evidence that LAR will receive approval without any black-box warnings. A major reason for our belief is that LAR really isn’t a new drug rather an improved version of an existing drug that has been on the market for nearly five years and is being used by more than one million patients. Unlike Victoza® which was approved with a black-box warning, the FDA is very familiar with what Byetta LAR is and what it is not.
The FDA has access to years of not just clinical data but years of real patient data, believe Diabetic Investor when we say that under the existing environment at the FDA, where they seem to be looking for reasons not to approve new drugs, that if there was a major – or even minor – issue with LAR it would have become public. What the facts tells us is that unlike Victoza® the FDA did not conduct or ask for a separate panel meeting. According to all the companies involved with LAR – Amylin (NASDAQ:AMLN), Lilly (NASDAQ:LLY) and Alkermes (NASDAQ:ALKS), the FDA has not asked for any additional data. From all outward appearances the FDA has everything they need to make a decision.
This obviously begs the question that if the FDA has everything they need why then did they not issue a decision yesterday. Given the absence of facts all we could do is speculate and when it comes to the FDA and why they do or don’t do something Diabetic Investor has learned its best not to speculate. Diabetic Investor suspects that Amylin will provide their perspective on what didn’t happen before the market opens on Monday to quell any fears that LAR is somehow off track. This could be a simple case that the FDA is behind in their work or it could be something else, but as we noted before this is just speculation and we have no hard facts.
So like everyone else Diabetic Investor will wait until Monday morning to see what Amylin has to say. This may not be what everyone wanted but as T H Huxley once said; “Truly it has been said, that to a clear eye the smallest fact is window which the Infinite may be seen.”
