FDA Approves SYMLIN Pen-Injector Devices Offering Convenience and Accuracy for SYMLIN Use
October 01 2007 - 7:00AM
PR Newswire (US)
SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) announced today that the U.S. Food and Drug
Administration (FDA) has approved the SymlinPen(TM) 120 and the
SymlinPen(TM) 60 pen-injector devices for administering SYMLIN(R)
(pramlintide acetate) injection. These new pre-filled pen-injector
devices feature simple, fixed dosing to improve mealtime glucose
control. "SymlinPen 120 and SymlinPen 60 offer patients improved
convenience and accuracy," said Daniel M. Bradbury, President and
CEO, Amylin Pharmaceuticals. "For people with diabetes using
mealtime insulin, the addition of SYMLIN can enhance glucose
control with the potential for weight loss." SymlinPen(TM) 60
features fixed dosing to deliver 15, 30, 45, or 60 micrograms per
dose. SymlinPen(TM) 120 features fixed dosing to deliver 60 or 120
micrograms per dose. Both pen-injector devices can be conveniently
stored at room temperature not to exceed 86 degrees F (30 degrees
C) after first use. The pens are expected to be available to
patients by December 2007. "Not Approvable" Letter Received for
SYMLIN Use with Basal Insulin Alone Amylin also announced today
that the FDA has issued a "Not Approvable" letter for SYMLIN use
with basal insulin (without mealtime insulin) in patients with type
2 diabetes who have not achieved desired glucose control. SYMLIN is
currently approved in the U.S. for patients with type 2 or type 1
diabetes who use mealtime insulin and need improved glucose
control. "SYMLIN remains an important therapeutic option for people
with diabetes who use mealtime insulin therapy," Bradbury added.
"We will initiate discussions with the FDA to clarify their
response for its use with basal insulin alone." About SYMLIN SYMLIN
is the first and only amylin mimetic for use in patients with
diabetes treated with mealtime insulin. SYMLIN is a synthetic
analog of human amylin, a naturally occurring hormone that is made
in the beta cells of the pancreas, the same cells that make
insulin. In patients with type 2 diabetes who use insulin, and in
patients with type 1 diabetes, those cells in the pancreas are
either damaged or destroyed, resulting in reduced secretion of both
insulin and amylin after meals. The use of SYMLIN contributes to
glucose control after meals. Healthcare professionals and people
with diabetes may obtain more information, including the complete
Prescribing Information and the Medication Guide, at
http://www.symlin.com/. Important Safety Information SYMLIN is not
intended for all patients with diabetes. SYMLIN is used with
insulin and has been associated with an increased risk of
insulin-induced severe hypoglycemia, particularly in patients with
type 1 diabetes. When severe hypoglycemia associated with SYMLIN
use occurs, it is seen within three hours following a SYMLIN
injection. If severe hypoglycemia occurs while operating a motor
vehicle, heavy machinery, or while engaging in other high- risk
activities, serious injuries may occur. Appropriate patient
selection, careful patient instruction, and insulin dose
adjustments are critical elements for reducing this risk. This
information is highlighted in a boxed warning in the SYMLIN
Prescribing Information for healthcare professionals and in a
Medication Guide for patients, which will be distributed by
pharmacists. Other adverse events commonly observed with SYMLIN
when co-administered with insulin were mostly gastrointestinal in
nature, including nausea, which was the most frequently reported.
The incidence of nausea was higher at the beginning of SYMLIN
treatment and decreased with time in most patients. The incidence
and severity of nausea are reduced when SYMLIN is gradually
increased to the recommended doses. About Diabetes Diabetes is a
complex metabolic disease characterized by high blood glucose
levels resulting from a deficiency of both insulin and amylin
secretion. Diabetes represents a large and growing market in the
United States, affecting more than 20 million Americans and growing
at three times the rate of population growth. Approximately 4.2
million patients with diabetes use insulin. Diabetes is the sixth
leading cause of death in the United States. Poor control of blood
glucose may result in severe long-term complications such as
cardiovascular disease, blindness, kidney failure, nerve damage and
amputation. About Amylin Pharmaceuticals, Inc. Amylin
Pharmaceuticals, Inc. 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(R) (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 located in San
Diego, California with over 1,800 employees nationwide. Further
information on Amylin Pharmaceuticals is available at
http://www.amylin.com/. This press release contains forward-looking
statements about Amylin, which involve risks and uncertainties. The
Company's actual results could differ materially from those
discussed due to a number of risks and uncertainties, including
risks that SYMLIN and SymlinPen may be affected by unexpected new
data, technical issues, or manufacturing and supply issues; risks
that the results of clinical trials may not be predictive of future
results; and risks inherent in the drug development and
commercialization process. Commercial and government reimbursement
and pricing decisions and the pace of market acceptance may also
affect the potential for SYMLIN and SymlinPen. These and additional
risks and uncertainties are described more fully in the Company's
most recently filed SEC documents, including its Form 10-Q. Amylin
undertakes no duty to update these forward-looking statements.
DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Alice Bahner
Izzo, Executive Director, Corporate Affairs of Amylin
Pharmaceuticals, Inc., +1-858-642-7272 Web site:
http://www.amylin.com/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Sep 2024 to Oct 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Oct 2023 to Oct 2024