Source: DGNews  |  Posted 2 years ago

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.