Exenatide Once Weekly Provided Superior Glucose Control Compared to Byetta in Tests


Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to Byetta (exenatide injection taken twice daily), in patients with type 2 diabetes.
The tests showed that after 24 weeks of treatment, patients taking exenatide once weekly experienced a statistically superior reduction in A1C, of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for Byetta. Patients treated with exenatide once weekly achieved a mean A1C of 7.1 percent compared with a mean A1C of 7.7 percent in those treated with Byetta. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking exenatide once weekly and 3.0 pounds for patients taking Byetta.
These findings are consistent with the results of other studies of exenatide once weekly and Byetta. The companies conducted DURATION-5 to support regulatory submissions outside of the U.S. and provide additional controlled clinical data on the commercially manufactured product. DURATION is a series of clinical trials designed to test the superiority of exenatide once weekly as compared to currently available type 2 diabetes medications.
Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by Byetta users (35 percent). There were no major hypoglycemic events. Cases of minor hypoglycemia in both groups were limited to patients using background sulfonylurea therapy.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the European Medicines Agency by the end of the second quarter in 2010.
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