Decline in Sales Results in Byetta Makeover?

San Diego,CAByetta makers are set to re-invent the drug, even though the jury isn't out on Byetta. The first byetta lawsuit was filed in August 2008, just two days after the FDA announced that it received six reports of hemorrhagic or necrotizing pancreatitis in patients taking the diabetes drug, two of whom died. Since late 2007 more reports of pancreatitis have emerged, resulting in a continued decline in sales of Byetta for Amylin, the manufacturer.

Amylin said sales of the twice-daily injectable diabetes treatment Byetta fell 20 percent to $140.7 million while sales of diabetes medication Symlin accounted for $21.8 million in revenue. The company's partner on the diabetes treatment Byetta is Eli Lilly & Co.

So Byetta makers are set to give Byetta a makeover.

Now the FDA is currently reviewing Bydureon, a once-weekly version of the twice-daily Byetta injection. Eli Lilly is a partner on that drug. As well, at the end of June 2010, Lilly announced final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among Byetta users was not increased compared to those patients using other antidiabetic therapies.

Back to the 2008 lawsuit. It alleges that Amylin and Eli Lilly possessed clinical data that justified a stronger warning label about pancreatitis compared to the warning language that Amylin eventually agreed to with the FDA. Mr Deleon, the plaintiff, was hospitalized in December of 2007 after developing pancreatitis, which causes inflammation of the pancreas and can lead to bleeding and death. Deleon's lawsuit contends that Amylin "failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk."

In the fall of 2007, Amylin agreed to add information about pancreatitis to the "precautions" section of the Byetta label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug. "It is pretty obvious that the label change in 2007 was not adequate," said Mr. Deleon's attorney, who also believes that "Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA." It will be interesting to see what happens with Bydureon--the FDA is expected to make a decision on the drug by Oct. 22.