Will Bydureon Suffer Same Fate as Byetta?

Washington, DCA recent observational study has found that Byetta carries no greater risk for acute pancreatitis than other Type 2 diabetes drugs available to the general public. However, the US Food and Drug Administration (FDA) has yet to acknowledge the study or update its guidance for Byetta on its official website. And with all attention on Bydureon, a new diabetes injection currently in development by co-manufacturers Amylin Pharmaceuticals Inc. and Eli Lilly and Company, concern for Byetta appears to have taken a back seat.

However, in its role as primary watchdog over medicinal drugs in the US, the FDA remains the last word on prescription drugs. If the FDA has taken a position on the retrospective study, presented in recent weeks at the annual meeting of the American Diabetes Association (ADA) in Orlando, it has yet to officially present its stance on its official website—suggesting that the safety updates dated November 9 of last year remain the regulator's position on the drug, until such a time as it updates the site with additional information.

The retrospective study concluded that Byetta was no better or worse with regard to risk for acute pancreatitis than any of its competitors in the type 2 diabetes sector.

Meanwhile, Obesity Fitness & Wellness Week reported earlier this month that an analysis of pooled safety data from three completed randomized and controlled trials demonstrated that Bydureon, the extended-release version of Byetta, intended as a once-per-week injection, was generally well-tolerated with a low discontinuation rate due to serious adverse events.

Other observations about the new drug currently in development centered on the variations of intensity with regard to side effects common to the two drugs. Nausea and vomiting, for example, were reported more frequently by Byetta users than Bydureon recipients.

The findings were also presented to the ADA conclave in Orlando, whose participants were likely encouraged about the findings.

However, the FDA approved Byetta with the same basket of good intentions in 2005, as it may do soon with Bydureon. And yet the FDA acknowledges that from April 2005 through October 2008 it received 78 adverse reaction reports about altered kidney function, acute renal failure and renal insufficiency.

The FDA urged a revision to the Byetta label. One wonders if a similar revision will be required of Bydureon, if approved, sometime down the road.