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Large Cardiovascular Outcomes Study To Be Initiated
Manufacturing Comparability Analysis Complete: Exenatide Once Weekly NDA Submission Remains On Track
To determine if there are favorable cardiovascular effects of exenatide
treatment, Lilly and Amylin intend to initiate a large cardiovascular outcomes
trial with a superiority design that will evaluate the effects of exenatide
once weekly on major cardiovascular events, compared to standard of care with
traditional antidiabetes medications. The global study will be sponsored by
Amylin and Lilly, and active discussions are ongoing to have the study led by
two academic research centers, The Diabetes Trial Unit at the Oxford Centre
for Diabetes (
"There is a major unmet need for proven therapies that can help reduce the excess cardiovascular morbidity and mortality associated with type 2 diabetes," commented Professor Holman. "This trial is designed to determine the extent to which exenatide may reduce cardiovascular risk, in addition to lowering glucose."
Exenatide Once Weekly NDA Submission On Track By End Of Second Quarter 2009
The analyses to demonstrate comparability necessary for the regulatory
submission of exenatide once weekly have been successfully completed and will
be part of the New Drug Application (NDA) submitted to FDA. These analyses
include data from the ongoing extension of the DURATION-1 study, and will be
used to support comparability between intermediate-scale clinical trial
material made in
"Both the manufacturing comparability data and the meta-analysis of the exenatide clinical trial database are key components of our submission. We believe that the material made at commercial scale is comparable to the clinical-scale material, and we are confident that we will have a strong submission package for exenatide once weekly," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. "If approved, this therapy has the potential to become the first weekly therapy to treat type 2 diabetes with glucose control and weight loss. This could offer a unique value proposition for patients, payers and physicians."
Initiation Of New DURATION-5 Clinical Study
The companies have initiated DURATION-5, a new phase 3b study in which
patients with type 2 diabetes will use exenatide once weekly commercial-scale
drug product in its final commercial configuration. This randomized, 26-week,
open-label study in approximately 240 patients has broad utility and is
designed to show superiority of exenatide once weekly compared to BYETTA,
support regulatory submissions outside the
"In the near-term, we are working to bring this important therapy to market as quickly as possible," said David Vondle, Lilly's global brand development leader for exenatide. "In the long-term, we are executing on a clinical trial program aimed to show superiority of exenatide once weekly over other diabetes medications."
Diabetes affects more than 23 million people in the
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
(i) The International Diabetes Federation Diabetes Atlas. Available at:
(ii) "All About Diabetes."
(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:
(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.
SOURCE CONTACT: Amylin, Web Site: http://www.amylin.com
(AMLN ALKS LLY)
Web Site: http://www.amylin.com