FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use
January 03 2007 - 7:00AM
PR Newswire (US)
Millions of People Using Thiazolidinediones Now Have New Treatment
Option to Manage Type 2 Diabetes SAN DIEGO and INDIANAPOLIS, Dec.
22 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) announced today
that the U.S. Food and Drug Administration (FDA) has approved
BYETTA(R) (exenatide) injection as an add-on therapy to improve
blood sugar control in people with type 2 diabetes who have not
achieved adequate control on a thiazolidinedione (TZD). Healthcare
professionals will be educated on this additional use for BYETTA in
the coming weeks. In a clinical trial designed to evaluate BYETTA
for use in combination with a TZD, 62 percent of patients who added
BYETTA to their existing medicines achieved an A1C (a measure of
blood glucose levels over time) of 7 percent or less, compared to
16 percent of the patients on placebo. People taking BYETTA also
lost an average of 3.3 pounds over 16 weeks, compared to an average
weight reduction of 0.4 pounds in the other group. The most common
adverse event associated with BYETTA was nausea (40 percent)(1)(2).
"Due to the progressive nature of type 2 diabetes, previous
approaches to management frequently failed to achieve target levels
of A1C, or resulted in subsequent failure over one to three years,"
said Dr. Robert Ratner, Vice President for Scientific Affairs at
the MedStar Research Institute in Washington, DC. "The combination
of exenatide with metformin, sulfonylureas, or TZDs not only
expands our options to achieve optimal glycemic control, but does
so with accompanying weight loss." BYETTA improves blood sugar
control by lowering both post-meal and fasting (early morning)
glucose levels resulting in better long-term control as measured by
A1C. BYETTA controls blood sugar through several physiologic
actions, including the stimulation of insulin secretion only when
blood sugar is high. BYETTA restores the first-phase insulin
response (an activity of the cells in the pancreas that is lost in
patients who have type 2 diabetes), decreases glucose output from
the liver, regulates gastric emptying, and decreases food intake.
The majority of patients in long-term BYETTA clinical studies also
experienced weight loss. "Almost half a million people with type 2
diabetes have used BYETTA to help reduce their blood sugar," said
Ginger L. Graham, Chief Executive Officer, Amylin Pharmaceuticals.
"Now, even more people -- those who use another common category of
oral medicines, TZDs -- have a new treatment option and have the
opportunity to benefit from the unique clinical benefits of
BYETTA." "There are two core defects to type 2 diabetes, beta cell
failure and insulin resistance," said Vince Mihalik, Global Brand
Development Leader for Diabetes and Endocrine, Lilly. "The ability
of BYETTA to improve beta cell responsiveness and lower weight
complements the TZD effect on insulin resistance very nicely."
About BYETTA BYETTA is the first in a new class of drugs for the
treatment of type 2 diabetes called incretin mimetics. 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
intestine, liver, pancreas and brain(3). BYETTA is approved by the
FDA for use by people with type 2 diabetes who are unsuccessful at
controlling their blood sugar levels despite using the commonly
prescribed oral medications metformin, a sulfonylurea, or a
thiazolidinedione. For full prescribing information, visit
http://www.byetta.com/. About Diabetes Diabetes affects more than
20 million in the United States and an estimated 194 million adults
worldwide(4)(5). Approximately 90-95 percent of those affected have
type 2 diabetes. People who have type 2 diabetes either do not
produce enough insulin and/or the cells in the body do not respond
normally to insulin. 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(6). Type 2
diabetes usually occurs in adults over the age of 40, but is
increasingly common in younger people. 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 target A1C levels (the target is less than
7.0%, according to American Diabetes Association guidelines) with
their current treatment regimen(7). Important Safety Information
for BYETTA(R) (exenatide) injection BYETTA improves blood sugar
control in patients with type 2 diabetes who are taking metformin,
a sulfonylurea, a thiazolidinedione, a combination of metformin and
a sulfonylurea, or a combination of metformin and a
thiazolidinedione, but have not achieved adequate glycemic control.
BYETTA is not a substitute for insulin in patients whose diabetes
requires insulin treatment. BYETTA is not recommended for use in
patients with problems digesting food or those who have severe
disease of the stomach or kidney. Before using BYETTA, patients
should tell their healthcare provider if they are pregnant, plan to
become pregnant, or are breastfeeding. BYETTA has not been studied
in children. Sulfonylureas, commonly used products among patients
with type 2 diabetes, can cause hypoglycemia (low blood sugar).
Therefore, when BYETTA is used with a medicine that contains a
sulfonylurea, there is an increased risk of this 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
most common when first starting BYETTA, but decreases over time in
most patients. BYETTA may reduce appetite, the amount of food
eaten, and body weight, however no changes in dose are needed for
these side effects. These are not all the side effects with BYETTA.
A healthcare provider should be consulted about any side effect
that is bothersome or does not go away. For complete safety profile
and other important prescribing considerations, 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, obesity and cardiovascular disease.
Amylin is located in San Diego, California with over 1,500
employees nationwide. Further information on 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 health care 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, Ind., 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
additional indications for BYETTA may not be received and/or that
BYETTA may be affected by unexpected new data or technical issues.
The potential for BYETTA may also be affected by competition,
government and commercial reimbursement and pricing decisions, the
pace of market acceptance and any issues related to manufacturing
and supply. These and additional risks and uncertainties are
described more fully in Amylin's and Lilly's most recently filed
SEC documents such as their Quarterly Reports on Form 10-Q. Amylin
and Lilly undertake no duty to update these forward-looking
statements. P-LLY (1) Bernard Zinman, Byron Hoogwerf, Santiago
Duran Garcia, Denai Milton, Joseph Giaconia, Dennis Kim, Michael
Trautmann, Robert Brodows. "Safety and Efficacy of Exenatide in
Patients with Type 2 Diabetes Mellitus Using Thiazolidenediones
with or without Metformin." Abstract presented at ADA 2006. (2)
Amylin Pharmaceuticals and Eli Lilly and Company press release.
"BYETTA(R) Shown to Reduce Blood Glucose Levels When Added to
Patients Using a TZD." Available at http://www.prnewswire.com/cgi-
bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/06-10-
006/0004378069&EDATE=Jun+10,+2006. Accessed November 13, 2006.
(3) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T,
Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4
(exenatide) significantly reduces postprandial and fasting glucose
in subjects with type 2 diabetes. Journal of Clinical Endocrinology
& Metabolism. 2003; 88(7):3082-3089. (4) The International
Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed April 12, 2005. (5) "All About
Diabetes." American Diabetes Association. Available at
http://www.diabetes.org/about-diabetes.jsp. Accessed November 9,
2006. (6) "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 November 9, 2006.
(7) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS.
Racial and ethnic differences in glycemic control of adults with
type 2 diabetes. Diabetes Care. 1999;22:403-408. DATASOURCE: Amylin
Pharmaceuticals, Inc.; Eli Lilly and Company CONTACT: Alice Bahner
of Amylin Pharmaceuticals, Inc., +1-858-642-7272, or cell,
+1-858-232-9072; or Jamaison Schuler of Lilly, +1-317-655-2111, or
cell, +1-317-997-1485 Web site: http://www.byetta.com/ Web site:
http://www.lillydiabetes.com/ Web site: http://www.amylin.com/
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