Amylin, Lilly update on FDA review of Byetta (exenatide) injection monotherapy submission

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company have announced that the U.S. Food and Drug Administration (FDA) is continuing with its review of the regulatory application for use of Byetta (exenatide) injection as stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control.

It is likely that this review will not be complete by the end of 2008, and may extend into 2009.

"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville G. Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "Importantly, we have not received any request for additional studies. We look forward to working closely with the agency as needed throughout the review process."

The regulatory application for use of Byetta as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other Byetta prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format.

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, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. Byetta was approved in April 2005 and has been used by approximately one million patients since its introduction.

Diabetes affects more than 23 million in the United States 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 United States and costs approximately $132 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 support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.

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.