BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
31 October 2009 - 11:16AM
PR Newswire (US)
Prescribing Information Also Includes Updated Safety Information
SAN DIEGO and INDIANAPOLIS, Oct. 30, 2009 /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) has approved an expanded indication for
BYETTA® (exenatide) injection. BYETTA is now approved for use as a
stand-alone medication (monotherapy) along with diet and exercise
to improve glycemic control in adults with type 2 diabetes.
Previously, it was approved for use only in patients who were also
taking other common diabetes medications and had not achieved
adequate glycemic control. "The expanded indication gives
physicians the option to prescribe BYETTA as a first-line
treatment, increasing the number of patients who may benefit from
the medication and providing an opportunity to treat patients with
BYETTA earlier in the disease," said Orville G. Kolterman, M.D.,
senior vice president of research and development, Amylin
Pharmaceuticals. "Type 2 diabetes is a complex disease, so it is
essential that healthcare professionals and their patients have a
wide array of treatments that can effectively control blood glucose
levels." The approval of BYETTA as a monotherapy treatment was
based on a clinical study of patients with type 2 diabetes who were
unable to achieve glycemic control through diet and exercise alone.
Study findings showed that patients treated with 5 mcg or 10 mcg of
BYETTA as monotherapy reduced their A1C, a measure of average blood
sugar over three months, by 0.7 percentage points and 0.9
percentage points, respectively, and lost 6.0 pounds and 6.4
pounds, respectively. Results of this study were published in
Clinical Therapeutics in August 2008.(i) Among treatment-emergent
adverse events, nausea was reported with the greatest incidence (5
mcg, 3 percent; 10 mcg, 13 percent). Hypoglycemia was reported in 5
percent of patients taking 5 mcg and 4 percent of patients taking
10 mcg, with no severe hypoglycemic events. In addition to the
monotherapy indication, the FDA approved changes to the BYETTA
Prescribing Information to incorporate updated safety information,
including pancreatitis-related language added to the Warnings and
Precautions section. This update addresses the alert issued by the
FDA in August 2008. The new label also expands upon existing
language regarding use of BYETTA in patients with renal impairment.
In addition, the label has been amended to match the format the FDA
currently uses for Prescribing Information. This label update is
being communicated to physicians via a "Dear Healthcare
Professional" letter, which will be available at
http://www.byetta.com/. "Patient safety is our foremost concern at
Amylin and Lilly, and the BYETTA Prescribing Information represents
an important way to communicate the information that healthcare
professionals and patients need in order to use the medication
safely and effectively," Kolterman continued. "Thus, the updated
label offers the most current information about the benefit-risk
profile of BYETTA as a foundational therapeutic choice for people
with type 2 diabetes." BYETTA has been used by more than one
million patients since market introduction in 2005. It has a proven
history with more than 10 million prescriptions written and 6.5
years of clinical experience. About Diabetes Diabetes affects more
than 24 million people in the United States and an estimated 246
million adults worldwide.(ii,iii) 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 $174 billion per year in direct and indirect medical
expenses.(iv) 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.(v) In addition, 85 percent of type 2 diabetes patients are
overweight and 55 percent are considered obese.(vi) Data indicate
that weight loss (even a modest amount) supports patients in their
efforts to achieve and sustain glycemic control.(vii,viii) About
BYETTA® (exenatide) injection BYETTA is the first and only
FDA-approved GLP-1 receptor agonist 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 an
injectable prescription medicine that may improve blood sugar
(glucose) control in adults with type 2 diabetes mellitus, when
used with a diet and exercise program. BYETTA is not insulin and
should not be taken instead of insulin. BYETTA is not recommended
to be taken with insulin. BYETTA is not for people with type 1
diabetes or people with diabetic ketoacidosis. BYETTA provides
sustained A1C control and low incidence of hypoglycemia when used
alone or in combination with metformin or a thiazolidinedione, with
potential weight loss. BYETTA is not a weight loss product. BYETTA
was approved in April 2005 and has been used by more than one
million patients since its introduction. For full prescribing
information, visit http://www.byetta.com/. Important Safety
Information for BYETTA® (exenatide) injection Based on
post-marketing data, BYETTA has been associated with acute
pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. The risk for getting low blood sugar is
higher if BYETTA is taken with another medicine that can cause low
blood sugar, such as a sulfonylurea. BYETTA should not be used in
people who have severe kidney problems, and should be used with
caution in people who have had a kidney transplant. Patients should
talk with their healthcare provider if they have severe problems
with their stomach, such as delayed emptying of the stomach
(gastroparesis) or problems with digesting food. Severe allergic
reactions can happen with BYETTA. The most common side effects with
BYETTA include nausea, vomiting, diarrhea, dizziness, headache,
feeling jittery, and acid stomach. Nausea most commonly happens
when first starting BYETTA, but may become less over time. These
are not all 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 Prescribing Information and
Medication Guide, visit http://www.byetta.com/. About Amylin and
Lilly Amylin Pharmaceuticals is a biopharmaceutical company
dedicated to improving lives of patients through the discovery,
development and commercialization of innovative medicines. Amylin
has developed and gained approval for two first-in-class medicines
for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA®
(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 on Amylin
Pharmaceuticals is available at http://www.amylin.com/. Through a
long-standing commitment to diabetes care, Lilly seeks to provide
patients with breakthrough treatments that enable them to live
longer, healthier, and fuller lives. Since 1923, Lilly has been an
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 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
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; label expansion requests not
being submitted in a timely manner or receiving regulatory
approval; approved label expansions not producing the results we
expect, 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'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. P-LLY (i) Moretto TJ, Milton DR, Ridge TD, et al.
Efficacy and tolerability of exenatide monotherapy over 24 weeks in
antidiabetic drug-naive patients with type 2 diabetes: a
randomized, double-blind, placebo-controlled, parallel-group study.
Clin Ther. 2008;30:1448-60. (ii) The International Diabetes
Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed Oct. 2, 2009. (iii) "All About Diabetes." American
Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed Oct. 2, 2009.
(iv) "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 Oct. 2, 2009. (v) Saydah SH, Fradkin J and Cowie CC. Poor
control of risk factors for vascular disease among adults with
previously diagnosed diabetes. JAMA. 2004;291:335-42. (vi) 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.
(vii) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes
Care. 2007;30 Suppl 1:S48-65. (viii) 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. DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT:
Anne Erickson of Amylin, +1-858-754-4443, cell, +1-858-349-3195, ;
or Kindra Strupp of Lilly, +1-317-277-5170, cell, +1-317-554-9577,
Web Site: http://www.amylin.com/ http://www.lilly.com/
http://www.lillydiabetes.com/
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