FDA also updated safety information to include pancreatitis-related language.

FDA has approved Amylin Pharmaceuticals and Eli Lilly’s Byetta® for use as a monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Additionally, the agency has updated Byetta prescribing information to include pancreatitis-related language in the warnings and precautions section.

Byetta was previously sanctioned for patients who were also taking other common diabetes medications and had not achieved adequate glycemic control. The new label also expands upon existing language regarding use of Byetta in patients with renal impairment.

The approval of Byetta as a monotherapy was based on a clinical study of patients who were unable to achieve glycemic control through diet and exercise alone. The study showed that 5 mcg or 10 mcg of Byetta reduced patients’ A1C, a measure of average blood sugar over three months, by 0.7 percentage points and 0.9 percentage points, respectively. Patients also lost 6.0 pounds and 6.4 pounds, respectively.

Lilly and Amylin each get 50% of Byetta’s gross margin in the U.S., and Lilly gets 100% of sales outside the U.S. Byetta has pulled in $592.8 million through worldwide sales during the first three quarters of this year. In the third quarter alone worldwide sales reached $205.7 million, a 2% increase compared with last year’s third quarter. U.S. sales of Byetta, however, declined 5% to $171.1 million compared with the same time period last year.

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