BYETTA Shown to Reduce Blood Sugar Levels When Added to Patients Treated With TZDs
November 15 2005 - 4:20PM
PR Newswire (US)
- More Than 60 Percent of Patients Achieved A1C Treatment Goal -
SAN DIEGO and INDIANAPOLIS, Nov. 15 /PRNewswire-FirstCall/ --
Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN) and Eli Lilly and
Company (NYSE:LLY) today announced positive results from a study of
BYETTA(R) (exenatide) injection used in addition to a common class
of oral diabetes medication called thiazolidinediones (or TZDs), in
people with type 2 diabetes who were not achieving acceptable blood
sugar control. Results from this study will form the basis of a
supplemental New Drug Application submission to the Food and Drug
Administration, currently planned for mid 2006. A1C, a measure of
glucose control over the previous three months, improved by
approximately 0.9 percentage points at the end of the 16-week study
for subjects receiving twice daily 10 microgram subcutaneous
injections of BYETTA in addition to their usual TZD or TZD plus
metformin regimen, compared to those on their prior oral
medications receiving placebo. At the beginning of the study, the
average A1C of study participants was approximately 7.9 percent.
Sixty-two percent of subjects receiving BYETTA who entered the
study with an A1C greater than 7 percent achieved an A1C of 7
percent or less compared to sixteen percent of similar subjects on
placebo. The American Diabetes Association recommends a target A1C
of less than 7 percent. Compared to placebo, subjects receiving
BYETTA experienced an average weight reduction of approximately
three pounds at 16 weeks. The most common adverse event was nausea,
which occurred in 40 percent of subjects receiving BYETTA compared
to 15 percent of those receiving TZD with placebo. No severe
hypoglycemia was observed. These results are consistent with those
seen in the AMIGO studies for BYETTA when BYETTA was added to other
commonly prescribed oral medications. This randomized,
placebo-controlled, double-blind study included 233 subjects with
type 2 diabetes who were not achieving adequate glucose control
using a TZD, a common oral diabetes medication, either alone or
with metformin. Subjects were randomized to receive BYETTA or
placebo for 16 weeks in addition to their usual TZD regimen. Those
receiving BYETTA received an introductory 5-microgram dose of
BYETTA for one month, given by subcutaneous injection twice a day,
followed by three months of 10 micrograms given twice a day. Amylin
and Lilly anticipate that the full study results will be presented
in a future scientific forum. About BYETTA BYETTA is the first in a
new class of drugs for the treatment of type 2 diabetes called
incretin mimetics and exhibits many of the same effects as the
human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1,
secreted in response to food intake, has multiple effects on the
intestine, liver, pancreas and brain that work in concert to
improve blood sugar.(1) About Incretin Mimetics Incretin mimetics
is a new class of treatment in the fight against diabetes. An
incretin mimetic works to mimic the anti-diabetic or
glucose-lowering actions of naturally occurring human hormones
called incretins. These actions include stimulating the body's
ability to produce insulin in response to elevated levels of blood
sugar, inhibiting the release of a hormone called glucagon
following meals, slowing the rate at which nutrients are absorbed
into the bloodstream and reducing food intake. BYETTA is the first
FDA-approved agent of this new class of medications. About Diabetes
Diabetes affects an estimated 194 million adults worldwide(2) and
more than 20 million in the United States.(3) Approximately 90-95
percent of those affected have type 2 diabetes, a condition where
the body does not produce enough insulin and/or the cells in the
body do not respond normally to insulin.(3) Diabetes is the sixth
leading cause of death by disease in the United States(3) and costs
approximately $132 billion per year in direct and indirect medical
expenses. Type 2 diabetes usually occurs in adults over the age of
40, but is increasingly common in younger people.(3) According to
the Centers for Disease Control and Prevention's National Health
and Nutrition Examination Survey, approximately 60 percent of
diabetes patients do not achieve target A1C levels (less than 7.0
percent according to American Diabetes Association guidelines(4))
with their current treatment regimen.(5) Important Safety
Information for BYETTA (exenatide) injection BYETTA (exenatide)
injection improves blood sugar control in patients with type 2
diabetes who are taking metformin, a sulfonylurea, or both. 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. BYETTA has not been studied in
children or pregnant women. When BYETTA is used with a medicine
that contains a sulfonylurea, low blood sugar (hypoglycemia) 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 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. No changes in dose are needed for
these side effects. These are not all the side effects with BYETTA.
A health care 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(TM)
(exenatide) injection. Further information on Amylin
Pharmaceuticals and its pipeline in metabolism is available at
http://www.amylin.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/. 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/. 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 factors,
including that future clinical trials may not replicate previous
trial results; BYETTA may not prove to be an important new
therapeutic option; the request to expand the indication for BYETTA
to include its use as an adjunct to TZDs may not receive regulatory
approval; risks and uncertainties inherent in the collaboration
with, and dependence upon, Lilly and/or Amylin; or BYETTA may be
affected by unexpected new data or technical issues. The potential
for BYETTA may also be affected by 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 and Lilly's most SEC filings, including our Form 10-Qs.
Amylin and Lilly undertake no duty to update these forward-looking
statements. P-LLY REFERENCES (1) 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. (2) The International Diabetes Federation Diabetes
Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed April 12, 2005. (3) Centers for Disease
Control and Prevention, National Diabetes Fact Sheet. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. (4) American
Diabetes Association. Standards of medical care in diabetes.
Diabetes Care 2005; 28:S4-36S. (5) 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. CONTACT:
Alice Bahner of Amylin, +1-858-552-2200; or Jamaison Schuler of
Lilly, +1-317-655-2111 Web site: http://www.amylin.com/
http://www.lilly.com/ http://www.byetta.com/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jul 2023 to Jul 2024