New Storage Instructions Approved for BYETTA(R)
February 20 2007 - 4:05PM
PR Newswire (US)
Refrigeration No Longer Required After First Use SAN DIEGO and
INDIANAPOLIS, Feb. 20 /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 more convenient patient storage
instructions for BYETTA(R) (exenatide) injection. BYETTA Pens can
now be kept at a room temperature not to exceed 77 degrees F (25
degrees C) after first use. With the updated label, refrigeration
of BYETTA is no longer required after first use. Patients can now
keep a BYETTA Pen at a temperature anywhere from 36 degrees F (2
degrees C) to 77 degrees F (25 degrees C) after first use. Until
first use, BYETTA Pens must continue to be stored in a refrigerator
between 36 degrees F (2 degrees C) and 46 degrees F (8 degrees C).
These new, more convenient storage instructions will be provided to
patients and healthcare professionals during the next few weeks.
Patients now using BYETTA can immediately begin storing their
current, in use BYETTA Pen at a room temperature not to exceed 77
degrees F (25 degrees C). BYETTA Pens should be protected from
light and never frozen. This change further enhances the
convenience of BYETTA for patients. BYETTA is available in a
simple-to-use 5 microgram and 10 microgram fixed dose pen device.
Unlike insulin, the dose of BYETTA does not need to be adjusted
based on the size of meals or amount of exercise, and no additional
blood glucose monitoring is required. "My patients already find
BYETTA simple and easy to use," said Deborah Hinnen, RN, ARNP, CDE,
BC-ADM, FAAN, Diabetes Nurse Specialist and Coordinator of Diabetes
Education Services, Mid America Diabetes Associates, Wichita,
Kansas. "The ability to store the BYETTA Pen without the need for
refrigeration after first use is an improved convenience that makes
it even easier for people with type 2 diabetes to take advantage of
the unique clinical benefits of BYETTA." Patients on BYETTA therapy
at 2.5 years showed sustained A1C control with a secondary benefit
of weight loss. BYETTA improved 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
helps control blood sugar through five unique actions in one
therapy, 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.
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(1). 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(2)(3). 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(4). 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(5). Important Safety Information
for BYETTA(R) (exenatide) injection BYETTA improves glucose (blood
sugar) control in patients with type 2 diabetes who are taking
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 with the stomach or food digestion, or those who
have severe kidney disease. 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. When BYETTA is used with a medicine that contains a
sulfonylurea, hypoglycemia (low blood sugar) 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
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.
Amylin's research and development activities leverage the company's
expertise in metabolism to develop potential therapies to treat
diabetes and obesity. Amylin is located in San Diego, California
with over 1,500 employees nationwide. For more information about
Amylin and the company's diabetes products, visit
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. (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) "All About Diabetes." American
Diabetes Association. Available at
http://www.diabetes.org/about-diabetes.jsp. Accessed November 9,
2006. (4) "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. (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. P-LLY DATASOURCE: Amylin Pharmaceuticals, Inc.
CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111; or Alice
Bahner of Amylin, +1-858-642-7272 Web site: http://www.amylin.com/
http://www.lilly.com/ http://www.byetta.com/
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