Amylin has agreed to add information regarding acute pancreatitis to the "Precautions" section of labeling for its type 2 diabetes therapy Byetta after FDA received 30 postmarketing reports of patients who developed the condition while taking exenatide, FDA announced in a Medwatch alert Oct. 16.

An "association between Byetta and acute pancreatitis is suspected in some of these cases," the agency stated.

Of 30 patients taking Byetta who developed acute pancreatitis, 27 had at least one other risk factor for the disease, such as gallstones, severe hypertriglyceridemia and alcohol use, FDA noted.

Twenty-two of those patients improved after discontinuing Byetta, and three reports indicate that symptoms returned when Byetta was restarted.

In six of the reports, symptoms began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily. In all, 21 patients were hospitalized, FDA said.

While there were no reports of hemorrhagic or necrotizing pancreatitis, five patients developed serious complications including dehydration and renal failure, suspected ileus, phlegmon and ascites.

Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdomen discomfort. However, FDA notes that patients should be informed that "the presence of unexplained severe abdominal pain, with or without nausea and vomiting, raises the suspicion of pancreatitis, a potentially serious condition that requires prompt medical attention."

"If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified," FDA said.

Byetta, an incretin mimetic for which Amylin is partnered with Lilly, is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

The company expects to release Phase III data during this quarter from a non-inferiority study comparing twice-daily Byetta with a once-weekly formulation called exenatide LAR it is developing with Lilly and Alkermes (¹ Also see "Exenatide LAR Phase III Non-Inferiority Data Anticipated In Q4, Amylin Says" - Pink Sheet, 24 July, 2007.).

-Shirley Haley (s.haley@elsevier.com)

Amylin Will Add Pancreatitis Cautions To Byetta Label

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