FDA Approve new diabetes treatment
The US Food and Drug Administration (FDA) has approved Byetta (exenatide) injection, developed by Amylin Pharmaceuticals and Eli Lilly as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved Byetta (exenatide) injection, developed by Amylin Pharmaceuticals and Eli Lilly as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes.
The therapy is for patients who have not achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications. Byetta is the first in a new class of medicines known as incretin mimetics.
Exenatide improves blood sugar control by lowering both postmeal and fasting glucose levels leading to better long-term control as measured by hemoglobin A1C. It does this through several actions, including the stimulation of insulin secretion only when blood sugar is high and by restoring the first- phase insulin response, an activity of the insulin-producing cells in the pancreas that is lost in patients who have type 2 diabetes. Most patients in the long-term clinical studies also experienced weight reduction.
'The availability of a treatment that lowers blood sugar and has the potential to help restore the response of the body's insulin-producing cells is an exciting advance for patients with type 2 diabetes,' said Dr David Kendall, medical director at International Diabetes Center in Minneapolis, Minnesota. 'It is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications.'
'Successfully managing diabetes is a daily struggle for millions,' said Ginger Graham, president and chief executive officer, Amylin Pharmaceuticals. 'Often, current treatments do not provide adequate blood sugar control leaving patients and caregivers frustrated. Byetta, a first-in-class medicine, is a new therapy for those who are not able to effectively control their blood sugar with their current oral medications.'
In addition to approving Byetta for use as an adjunct to existing oral medicines, the FDA also stated that the product is approvable as a monotherapy for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six- month review.
About Byetta
Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the stomach, liver, pancreas and brain that work in concert to regulate blood sugar.1 Byetta was approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea or both.
About Incretin Mimetics
Incretin mimetics is a new class of therapeutics for use in the fight against type 2 diabetes. An incretin mimetic works to mimic the antidiabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. Byetta is the first FDA-approved agent of this new class of medications.
About diabetes
Diabetes affects an estimated 194 million adults worldwide2 and more than 18 million in the United States.3 Approximately 90 to 95 percent of those affected have type 2 diabetes, a condition where the body does not produce enough insulin and/or the cells in the body do not respond normally to insulin.3 Diabetes is the fifth leading cause of death by disease in the United States4 and costs approximately $132 billion per year in direct and indirect medical expenses. Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.3
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of diabetes patients do not achieve target hemoglobin A1C levels (less than 7 percent according to American Diabetes Association guidelines5 with their current treatment regimen.6
References
(1) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003; 88(7):3082- 3089.
(2) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.
(3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf.
(4) Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002. National vital statistics reports; vol 53 no 5. Hyattsville, Maryland: National Center for Health Statistics. 2004.
(5) American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005;28:S4-36S.
(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999;22:403-408.