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Diabetes drug Byetta approved by US FDA

The new diabetes drug Byetta mimics the action of human hormones which lower glucose levels. Such drugs are called incretin mimetics. Byetta is the first in a class of such incretin mimetics



Aril 30, 2005: The United States FDA (USFDA) has approved the use of Byetta, a drug derived from the saliva of the Gila monster, as a treatment for diabetes mellitus Type 2. 

Byetta, also known as exenatide injections, has been approved as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications. Byetta is the first in a new categry of medicines known as incretin mimetics. Byetta will be available to pharmacies by June 1, 2005.

Byetta is made by Amylin Pharmaceuticals and Eli Lilly of US.

Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. Incretin mimetics is a new class of therapeutics for use in the fight against type 2 diabetes. An incretin mimetic mimics 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.

Byetta improves blood sugar control by lowering both post-meal and fasting glucose levels, leading to better long-term control. Byetta 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. A majority of patients in the long-term Byetta clinical studies also experienced reductions in weight.

Diabetes affects an estimated 194 million adults worldwide and over 18 million in the US. Approximately 90 to 95% of those affected have Type 2 diabetes, when the human body does not produce sufficient insulin and/or the body's cells 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. It usuallly occurs in adults older than 40, but is nowadays among younger people too.

Talking about Byetta, Dr. David Kendall, Medical Director at International Diabetes Center in Minneapolis, Minnesota, and an investigator for the BYETTA clinical studies said: "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. Byetta is a truly unique tool for the management of type 2 diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications."

Ginger L. Graham, President and Chief Executive Officer, Amylin Pharmaceuticals, Inc said: "Successfully managing diabetes is a daily struggle for millions of Americans. 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."

"Byetta offers an exciting new option for people with type 2 diabetes and marks an important milestone for Amylin and Lilly's successful collaboration," said Sidney Taurel, Chairman and Chief Executive Officer, Eli Lilly and Company. "With Byetta's demonstrated effects on blood sugar and its safety profile, physicians and patients now have a new approach to fight the growing diabetes epidemic."

In addition to approving Byetta for use as an adjunct to existing oral medicines, the FDA also stated that Byetta is approvable as a stand-alone therapy (monotherapy) for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six- month review.

Byetta is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals. Byetta will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device.

Safety and Tolerability Information

In the three 30-week controlled trials, adverse events associated with Byetta were generally mild to moderate in intensity. The most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy in most patients who initially experienced nausea, the frequency and severity decreased over time.

Patients receiving Byetta in combination with a sulfonylurea have an increased risk of hypoglycemia; to reduce this risk, reduction in the dose of the sulfonylurea should be considered, the manufacturers said. In the 30-week controlled clinical trials, hypoglycemia appeared to be dependent on the doses of both Byetta and a sulfonylurea. Most episodes of hypoglycemia were mild to moderate in intensity and all were resolved with oral administration of carbohydrate. No increased risk of hypoglycemia was observed in the 30-week controlled studies with Byetta when used in combination with metformin compared to placebo.

The drugmakers also advise patients that treatment with Byetta may result in a reduction in appetite, food intake, and/or body weight and that there is no need to modify the dosing regimen due to such effects.

Byetta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, nor is Byetta a substitute for insulin in insulin-requiring patients. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.

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 guidelines with their current treatment regimen.

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism is available at .

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  .

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  .


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