SAN DIEGO and INDIANAPOLIS, Dec. 22,
2010 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:
AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that a
supplemental New Drug Application (sNDA) has been submitted to the
U.S. Food and Drug Administration (FDA) for the expanded use of
BYETTA® (exenatide) injection as an add-on therapy to basal
insulin, with or without metformin and/or a thiazolidinedione (TZD)
in conjunction with diet and exercise for adults with type 2
diabetes who are not achieving adequate glycemic control.
BYETTA, the first marketed GLP-1 receptor agonist, was approved
in the U.S. in April 2005 for the
treatment of type 2 diabetes as add-on therapy to diet and exercise
for adult patients not achieving adequate glycemic control using
commonly prescribed oral diabetes medications. In October 2009, BYETTA was approved as monotherapy
along with diet and exercise. BYETTA is available in more than 60
countries worldwide.
"Many patients using basal insulin with or without oral diabetes
medications are unable to maintain adequate blood sugar control,
particularly at mealtime," said Orville G.
Kolterman, M.D., senior vice president, chief medical
officer, Amylin Pharmaceuticals. "If approved for this expanded
use, BYETTA may provide a complementary addition to basal insulin
to improve overall blood sugar control with no weight gain and no
increased risk of hypoglycemia. The combination may also offer a
mealtime treatment option that is taken only twice a day and does
not require dosing titration."
The sNDA is based on a double-blind, placebo-controlled clinical
study evaluating BYETTA added to Lantus® (insulin glargine). The
study showed many hard-to-treat patients with type 2 diabetes who
were poorly controlled on basal insulin therapy with or without
metformin and/or a TZD achieved A1C control without weight gain or
increasing their risk of hypoglycemia. A total of 261 patients
receiving insulin glargine, with or without oral agents, were
randomized to receive BYETTA or placebo in addition to aggressive
insulin titration. After 30 weeks of treatment, A1C on average
decreased by 1.7 percentage points in patients adding BYETTA,
compared with a decrease of 1.0 percentage point in patients
treated with insulin alone. Both treatment groups showed lower
fasting plasma glucose concentrations; however, after morning and
evening meals, when BYETTA was administered, postprandial glucose
control was significantly improved with BYETTA compared to placebo.
On average, weight decreased by 4 pounds in patients adding BYETTA,
compared with an increase of 2 pounds in patients treated with
insulin alone. The greater improvement in A1C with BYETTA was not
accompanied by an increase in hypoglycemia, compared to
placebo.
Nausea was the most common adverse event during the 30-week
treatment period and decreased over time. Nausea occurred in 41
percent of patients treated with BYETTA compared with 8 percent of
patients treated with insulin alone. Hypoglycemia was similar for
both groups; major hypoglycemia occurred twice in one patient
receiving insulin alone.
The study was published in the Dec. 7,
2010 Annals of Internal Medicine.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an
estimated 285 million adults worldwide.(i), (ii) Approximately
90-95 percent of those affected have type 2 diabetes. Diabetes
costs approximately $174 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 indicate that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi), (vii)
About BYETTA® (exenatide) injection
BYETTA was the first 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
currently recommended to be taken with insulin. BYETTA is not for
people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used alone or in combination with metformin or a
TZD, with potential weight loss (BYETTA is not a weight-loss
product). BYETTA was approved in April
2005 and has been used by more than 1.3 million patients
since its introduction. See important safety information below.
Additional information about BYETTA is available at
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 additional important safety information about
BYETTA, please see the full Prescribing Information
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
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. Further information on
Amylin Pharmaceuticals is available at 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 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, Lilly provides
answers - through medicines and information - for some of the
world's most urgent medical needs. Additional information about
Lilly is available at 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/or the
revenues generated from BYETTA, may be affected by competition;
unexpected new data; safety and technical issues; clinical trials,
including the trial mentioned in this press release, not being
completed in a timely manner, not confirming previous results, not
being predictive of real-world use, or not achieving the intended
clinical endpoints; label expansion requests, including the request
mentioned in this press release, not 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 development
and commercialization of pharmaceutical products, including those
inherent in the collaboration with and dependence upon Amylin
and/or Lilly. 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.
BYETTA® is a registered trademark of Amylin
Pharmaceuticals, Inc. All other marks are the marks of their
respective owners.
P-LLY
(i) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed December 16, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed December 16, 2010.
(iii) Direct and Indirect Costs of Diabetes in the United States. American Diabetes
Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed December 16, 2010.
(iv) 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.
(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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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company