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FDA approved expanded indication for exenatide
The FDA has approved exenatide injection for use as monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other antidiabetic agents and had not achieved adequate glycemic control.
The approval of exenatide (Byetta, Amylin and Eli Lilly and Company) as a monotherapy treatment was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. Study findings showed that patients reduced their HbA1c by 0.7% with the 5-mcg dose and by 0.9% with the 10-mcg dose. Patients assigned to the 5-mcg dose also lost 6 lb and those assigned to the 10-mcg dose lost 6.4 lb. These data were published in Clinical Therapeutics in August 2008.
Nausea was reported with the greatest incidence (5 mcg, 3%; 10 mcg, 13%). Hypoglycemia was reported in 5% of patients assigned to the 5-mcg dose and 4% of patients assigned to the 10-mcg dose; no severe hypoglycemic events were reported.
In addition to the monotherapy indication, the FDA approved changes to the prescribing information to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions section. This update addresses the alert issued by the FDA in August 2008. The new label also expands upon existing language regarding use of exenatide in patients with renal impairment.
