Monotherapy BYETTA(R) Showed Significant Improvement in Glucose Control and Weight Loss in Adults with Type 2 Diabetes
December 06 2007 - 6:00AM
PR Newswire (US)
- FDA Submission Planned in First Half of 2008 - SAN DIEGO and
INDIANAPOLIS, Dec. 6 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company
(NYSE:LLY) today announced study results from a 24-week study of
monotherapy, or stand-alone, BYETTA (exenatide) injection taken
twice daily in drug-naive patients with type 2 diabetes. Study
participants taking 5 mcg or 10 mcg of monotherapy BYETTA twice
daily showed significant reductions in A1C (a measure of average
blood sugar over 3 months) by 0.7 percentage points and 0.9
percentage points, respectively, from an average baseline A1C
ranging from 7.8 to 7.9 percent. In addition, approximately 60
percent of study participants on either 5 mcg or 10 mcg of
monotherapy BYETTA at the conclusion of the study had an A1C of 7
percent or less, a common target for good glucose control. The
companies plan a regulatory submission to the U.S. Food and Drug
Administration (FDA) in the first half of 2008. In this 24-week,
randomized, placebo-controlled study, 232 drug-naive people with
type 2 diabetes were treated with monotherapy BYETTA or placebo.
More than 85 percent of study participants in the 5 mcg and 10 mcg
arms completed the study. Weight loss from baseline was significant
and similar to that observed in previous BYETTA studies. "The
American Diabetes Association's (ADA) clinical guidelines for the
treatment of patients with type 2 diabetes are to achieve target
glucose control, as well as weight loss in overweight or obese
patients," said James Malone, M.D., Global Medical Director, Eli
Lilly and Company. "These data are robust and are consistent with
data from other trials that support the use of BYETTA before
starter insulin. If approved for monotherapy, BYETTA may provide an
additional treatment option for physicians to consider earlier in
the continuum of care." There was a low incidence of nausea
reported in both treatment arms of the study of approximately 3 and
13 percent in the 5 mcg and 10 mcg arms, respectively. There were
no instances of severe hypoglycemia in this study. Overall
hypoglycemia observed was similar to that seen in studies where
BYETTA was used in conjunction with metformin only. BYETTA -- the
first and only FDA-approved incretin mimetic -- was approved in
April 2005 and has been used by more than 700,000 patients since
its introduction. BYETTA is indicated as an add-on therapy for use
twice a day in adults with type 2 diabetes who are unsuccessful at
controlling their blood sugar levels using common oral diabetes
medications. This study was conducted following receipt of an
approvable letter for a monotherapy indication from the FDA in
2005. Study Design The 24-week, randomized study included 232
people with type 2 diabetes who were not achieving adequate glucose
control using diet and exercise without previous use of
antidiabetes agents. Study participants were randomized to receive
subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg
exenatide twice daily without taking any oral antidiabetes agents.
Patients randomized to 10 mcg exenatide received 5 mcg injections
for the first 4 weeks, and increased to 10 mcg injections for the
final 20 weeks. Full study results will be included in future
scientific publications. About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs called incretin mimetics
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 thiazoladinedione, and
progressive weight loss. For full prescribing information, visit
http://www.byetta.com/. About Diabetes Diabetes affects more than
21 million in the United States and an estimated 246 million adults
worldwide (1,2). 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 (3). 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 (4). Important Safety
Information for BYETTA BYETTA improves 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, 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. 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 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.
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 with over 1,800 employees nationwide. 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 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, 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, technical issues, clinical trials not confirming previous
results, pre-clinical trials not predicting future results, label
expansion requests, including the FDA submission referred to in
this press release, not being submitted in a timely manner or
receiving regulatory approval, or manufacturing and supply issues.
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 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) The
International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed November 27, 2007. (2) "All About
Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed November 27,
2007. (3) "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 27, 2007.
(4) 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. DATASOURCE: Amylin
Pharmaceuticals, Inc.; Eli Lilly and Company CONTACT: Kindra Strupp
of Lilly, +1-317-277-5170, cell, +1-317-554-9577; or Alice Izzo of
Amylin, +1-858-642-7272, cell, +1-858-232-9072 Web site:
http://www.amylin.com/ http://www.lilly.com/
http://www.lillydiabetes.com/ http://www.byetta.com/
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