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| Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes |
"The exenatide once weekly submission is an important milestone in the
overall exenatide development program. The clinical data supporting this
submission highlight the potential of exenatide once weekly to significantly
advance the treatment of type 2 diabetes," said Clinical components of the NDA include the DURATION-1 study and the meta-analysis of primary cardiovascular events across the BYETTA clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to BYETTA, which is administered twice daily. In this study, exenatide once weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseline, compared to a reduction of 1.5 percentage points for BYETTA, and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with BYETTA. Exenatide once weekly and BYETTA were both associated with an average weight loss of 8 pounds from baseline. The most commonly reported adverse event was nausea, which was typically mild and transient and occurred less frequently in the exenatide once weekly patients. In addition, a meta-analysis across controlled clinical studies of three months or greater from the BYETTA database showed no increased risk of cardiovascular events associated with exenatide use. This analysis applied principles outlined in the FDA's guidance for evaluating cardiovascular risk in type 2 diabetes agents. Components of the submission supporting product manufacturing include
analyses to demonstrate comparability of the intended commercial product with
that used during development. These analyses include data from patients in the
ongoing extension of the DURATION-1 study who used exenatide once weekly
produced at Amylin's manufacturing facility in "If approved, exenatide once weekly would be the first and only once-a-week therapy for the treatment of type 2 diabetes," said David Vondle, exenatide global brand development leader for Lilly. "A new treatment option to help patients with type 2 diabetes manage blood sugar, with potential weight loss and less frequent dosing, could offer an important advance in the treatment paradigm for patients and physicians who manage this chronic condition." About Diabetes Diabetes affects more than 23 million people in the U.S. and an estimated
246 million adults worldwide.(i,ii) 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 costs approximately According to the Centers for Disease Control and Prevention's About BYETTA(R) (exenatide) injection 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 Important Safety Information for BYETTA 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. For full prescribing information, visit www.BYETTA.com. About Amylin, Lilly and Amylin, Lilly, and 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 healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. 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
This press release contains forward-looking statements about Amylin, Lilly
and P-LLY (i) "All About Diabetes." (ii) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed (iii) "Direct and Indirect Costs of Diabetes in the (iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for
vascular disease among adults with previously diagnosed diabetes." JAMA:
291(3), (v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47. (vi) Nutrition Recommendations and Interventions for Diabetes: a position
statement of the (vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
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