Amylin, Lilly Update on FDA Review of BYETTA(R) (exenatide) Injection Monotherapy Submission
December 08 2008 - 8:00AM
PR Newswire (US)
SAN DIEGO and INDIANAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company
(NYSE:LLY) today announced that the U.S. Food and Drug
Administration (FDA) is continuing with its review of the
regulatory application for use of BYETTA(R) (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.
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, 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. For full prescribing information,
visit http://www.byetta.com/. About Diabetes Diabetes affects more
than 23 million in the United States 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 United States and costs approximately
$132 billion per year in direct and indirect medical expenses.
(iii) 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.(iv) In addition,
85 percent of type 2 diabetes patients are overweight and 55
percent are considered obese.(v) Data support that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi,vii) 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 http://www.byetta.com/. About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and
commercialization of innovative medicines. Amylin has developed and
gained approval for two first- in-class medicines for diabetes,
SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide)
injection. Amylin's research and development activities leverage
the company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego, California. Further information about Amylin
Pharmaceuticals is available at http://www.amylin.com/. 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. For
more information about Lilly's current diabetes products visit,
http://www.lillydiabetes.com/. 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 Indianapolis, Indiana, Lilly provides answers - through
medicines and information - for some of the world's most urgent
medical needs. Additional information about Lilly is available at
http://www.lilly.com/. This press release contains forward-looking
statements about Amylin and Lilly. Actual results could differ
materially from those discussed or implied in this press release
due to a number of risks and uncertainties, including the risk that
BYETTA and the revenues generated from BYETTA may be affected by
competition; unexpected new data; safety and technical issues;
clinical trials not confirming previous results; pre-clinical
trials not predicting future results; or regulatory applications,
including the regulatory application mentioned in this press
release, not being submitted in a timely manner or receiving
regulatory approval. The potential for BYETTA may also be affected
by government and commercial reimbursement and pricing decisions,
the pace of market acceptance, or scientific, regulatory and other
issues and risks inherent in the commercialization of
pharmaceutical products. These and additional risks and
uncertainties are described more fully in Amylin's and Lilly's most
recent SEC filings including their Quarterly Reports on Form 10-Q
and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty
to update these forward-looking statements. i The International
Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 2, 2008. ii "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 8, 2008.
iii "Direct and Indirect Costs of Diabetes in the United States."
American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed June 8, 2008. 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), January 21, 2004. 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 American Diabetes Association. Diabetes
Care. 2007;30 Suppl 1:S48-65. 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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DATASOURCE: Eli Lilly and Company CONTACT: Alice Izzo of Amylin,
+1-858-642-7272, Cell +1-858-232-9072, ; or Kindra Strupp of Lilly,
+1-317-277-5170, Cell +1-317-554-9577, Web site:
http://www.lilly.com/ http://www.lillydiabetes.com/
http://www.amylin.com/ http://www.byetta.com/
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