New Storage Instructions Approved for ByettaRefrigeration No Longer Required After First Use
SAN DIEGO and INDIANAPOLIS, February 20, 2007 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved more convenient patient storage instructions for BYETTA(R) (exenatide) injection. BYETTA Pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use.
With the updated label, refrigeration of BYETTA is no longer required after first use. Patients can now keep a BYETTA Pen at a temperature anywhere from 36 degrees F (2 degrees C) to 77 degrees F (25 degrees C) after first use. Until first use, BYETTA Pens must continue to be stored in a refrigerator between 36 degrees F (2 degrees C) and 46 degrees F (8 degrees C). These new, more convenient storage instructions will be provided to patients and healthcare professionals during the next few weeks. Patients now using BYETTA can immediately begin storing their current, in use BYETTA Pen at a room temperature not to exceed 77 degrees F (25 degrees C). BYETTA Pens should be protected from light and never frozen.
This change further enhances the convenience of BYETTA for patients. BYETTA is available in a simple-to-use 5 microgram and 10 microgram fixed dose pen device. Unlike insulin, the dose of BYETTA does not need to be adjusted based on the size of meals or amount of exercise, and no additional blood glucose monitoring is required.
"My patients already find BYETTA simple and easy to use," said Deborah Hinnen, RN, ARNP, CDE, BC-ADM, FAAN, Diabetes Nurse Specialist and Coordinator of Diabetes Education Services, Mid America Diabetes Associates, Wichita, Kansas. "The ability to store the BYETTA Pen without the need for refrigeration after first use is an improved convenience that makes it even easier for people with type 2 diabetes to take advantage of the unique clinical benefits of BYETTA."
Patients on BYETTA therapy at 2.5 years showed sustained A1C control with a secondary benefit of weight loss. BYETTA improved blood sugar control by lowering both post-meal and fasting (early morning) glucose levels, resulting in better long-term control as measured by A1C. BYETTA helps control blood sugar through five unique actions in one therapy, including the stimulation of insulin secretion only when blood sugar is high. BYETTA restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake.
BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, liver, pancreas and brain(1). BYETTA is 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 a thiazolidinedione. For full prescribing information, visit www.BYETTA.com.
Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide(2)(3). Approximately 90-95 percent of those affected have type 2 diabetes. People who have type 2 diabetes either do not produce enough insulin and/or the cells in the body do not respond normally to insulin. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses(4). Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve target A1C levels (the target is less than 7.0%, according to American Diabetes Association guidelines) with their current treatment regimen(5).
Important Safety Information for BYETTA(R) (exenatide) injection
BYETTA improves glucose (blood sugar) control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems with the stomach or food digestion, or those who have severe kidney disease. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For complete safety profile and other important prescribing considerations, visit www.BYETTA.com.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,500 employees nationwide. For more information about Amylin and the company's diabetes products, visit www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products visit www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that additional indications for BYETTA may not be received and/or that BYETTA may be affected by unexpected new data or technical issues. The potential for BYETTA may also be affected by competition, government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin's and Lilly's most recently filed SEC documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to update these forward-looking statements.
(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) "All About Diabetes." American Diabetes Association. Available at http://www.diabetes.org/about-diabetes.jsp. Accessed November 9, 2006.
(4) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed November 9, 2006.
(5) 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.
CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111; or Alice Bahner ofAmylin, +1-858-642-7272
Ticker Symbol: (NASDAQ-NMS:AMLN),(NYSE:LLY)
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Posted: February 2007
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