SAN DIEGO and INDIANAPOLIS -- November 2, 2009 -- The US Food and Drug Administration (FDA) has approved exenatide (Byetta) injection for use as monotherapy along with diet and exercise to improve glycaemic control in adults with type 2 diabetes. This is an expanded indication for the drug, which was previously approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycaemic control.
The approval of exenatide as a monotherapy treatment was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycaemic control through diet and exercise alone. Study findings showed that patients treated with 5 mcg or 10 mcg of exenatide as monotherapy reduced their haemoglobin (Hb) A1C by 0.7% and 0.9%, respectively, and lost 6.0 lb and 6.4 lb, respectively. Results of this study were published in Clinical Therapeutics in August 2008.
Among treatment-emergent adverse events, nausea was reported with the greatest incidence (5 mcg, 3%; 10 mcg, 13%). Hypoglycaemia was reported in 5% of patients taking exenatide 5 mcg and 4% of patients taking 10 mcg, with no severe hypoglycaemic events.
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. In addition, the label has been amended to match the format the FDA currently uses for Prescribing Information.
Exenatide, a GLP-1 receptor agonist, exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves Hb A1C after food intake through multiple effects that work in concert on the stomach, liver, pancreas, and brain.
SOURCE: Amylin Pharmaceuticals, Inc.
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