NDA for Exenatide once weekly accepted for FDA review

Jul 7 2009

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week. Exenatide is the active ingredient in Byetta (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.

"Acceptance of the NDA submission for exenatide once weekly is an important milestone both in the exenatide development program and in the treatment of type 2 diabetes," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin Pharmaceuticals. "If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week."

Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide. Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and results in approximately $174 billion per year in direct and indirect medical expenses.

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 their target blood sugar levels with their current treatment regimen. In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese. Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.

Byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. 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 stomach, liver, pancreas and brain. Byetta is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. Byetta is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. Byetta provides sustained A1C control and low incidence of hypoglycemia when used with metformin or a thiazolidinedione, with potential weight loss. Byetta is not a weight loss product. Byetta was approved in April 2005 and has been used by more than one million patients since its introduction. For full prescribing information, visit www.Byetta.com.

Byetta improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with 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 digesting food or those who have severe disease of the stomach or kidney.

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 the most common side effect when first starting Byetta, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. 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 of the side effects from use of Byetta. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

http://www.Byetta.com