Some clarity from the FDA on Byetta

Some clarity from the FDA on Byetta

As shares of Amylin (NASDAQ:AMLN) continue to plummet investors may be wise to buck conventional thinking. Looking for more clarity on the Byetta pancreatitis issue Diabetic Investor emailed several questions to the FDA and below is the both our questions and the FDA’s answers:

Is the FDA saying that there is a causal relationship here – simple put does using Byetta cause pancreatitis?

"FDA continues to consider this a rare or uncommon event." 

Do we have any idea if the six patients were already at increased risk for pancreatitis? 

"5/6 (83%) of the cases were associated with at least one contributory factor that alone could have caused the patient’s pancreatitis, including concomitant drug therapy, concurrent disease state, or both.  However, with regard to a medical history of pancreatitis or gall bladder disease: three patients were reported as having no history of past pancreatitis or gall bladder disease; 1 patient was reported as having no history of gall bladder disease; 1 patient was reported as having no history of past pancreatitis, but had undergone a cholecystectomy.  For one patient, there was no medical history stated in the report."
Where these patients on any other medications?

"All of these patients were on concomitant medications with the exception of one patient for whom concomitant medications were not listed in the report".
I am assuming that the six patients are not part of the original 30 cases, is that correct?

"That is correct."
Since there is already information about this on the Byetta label – is the next step a black box warning?

"FDA is working with the maker of exenatide, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings
in the Byetta prescribing information about the risk of serious risk of acute hemorrhagic or necrotizing pancreatitis."
Will there be any public hearings on this issue or will it be settled internally between Amylin, Lilly and the FDA?

"No public hearings are scheduled or anticipated at this time."

Given that the FDA considers this issue to be a “rare or uncommon event”, it makes one wonder if the agency was experiencing a CYA moment when they issued their earlier release (which Diabetic Investor published during our early alert). It should also be asked if the FDA has something against diabetes as the patients who take Byetta and physicians who prescribe the drug will react to the headlines rather than take the time to investigate further. This is not unlike what happened to Avandia.
While there will be endocrinologists and diabetologiests who will look beyond the headlines, primary care physicians who treat nearly 80% of the people who have diabetes do not have the time to look beyond the headline. Just as these physicians took their patients off Avandia before all the evidence was heard, look for a similar result for Byetta.

Once again the biggest loser here is the patient with diabetes. While it’s true that pancreatitis is a serious concern, the FDA is not saying that Byetta causes pancreatitis. They are not saying physicians should not prescribe the drug nor does it appear they are considering a black box warning for the drug. Why they did not state in their earlier note to physicians that this is a “rare or uncommon event” is anyone’s guess.

The fact is every drug has side effects and no drug is free from adverse events. This is the nature of the beast. Improper use of insulin can cause severe hypoglycemia a serious and life threatening event, yet the FDA does not issue any warnings on insulin usage. There has already been a label change for Januvia over the possible risk of a serious life threatening form of skin cancer. Patients on Actos experience weight gain, edema and an increased incidence of bone fractures. Metformin, the most widely prescribed drug to treat diabetes, can have serious gastrointestinal side effects.

Diabetes is a serious health and economic issue and the agency that is supposed to be helping patients and physicians is only making matters worse with their lack of information.  The fact is that there is a correlation between pancreatitis and diabetes. It is also true with just six cases of pancreatitis and nearly 1 million patients on Byetta (we early reported the number of patients using Byetta at 800,000 and have since received an update number from Amylin) the numbers speak for themselves. Diabetic Investor is willing to wager that the incidence of pancreatitis and Byetta usage is lower than overall incidence rate for diabetes and pancreatitis no matter what therapy is used.

One also has to wonder has the agency created another headache. How can they approve Liraglutide from Novo Nordisk (NYSE:NVO) without asking for more information on this issue. And what about Roche, who also has a long-acting GLP-1 under development, does this mean they will need to do even more studies? What about Amylin and their long-acting once-week version of Byetta, so close to FDA submission. Will this issue throw a monkey wrench into that submission?

No one is arguing that the agency should not keep the public and physicians informed if a possible issue exists with a particular therapy. However, they should also have the common sense to know their statements can and do have an impact in the real world. 

Unfortunately for Amylin shareholders and the nearly 1 million patients using Byetta, the agencies lack of clarity has done more harm than good. Physicians will surly receive calls from their patients, who hopefully will not automatically take their patients off Byetta, as so many did with Avandia. The fact is Byetta is safe and very effective. Few drugs even come close to matching its proven glucose control and ability to help patient’s loss weight.
While Diabetic Investor believes shares of Amylin may suffer over the near term we are not backing away from our earlier statements that Amylin is the most valuable property in diabetes and that Byetta LAR when approved will be a paradigm shifting technology for the treatment of Type 2 diabetes. Opportunity is knocking here for those bold enough to understand all the facts. Over the years this stock has taken some serious hits and each time come back to be stronger than before.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile