Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
May 05 2009 - 8:00AM
PR Newswire (US)
SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., May 5
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.,
(NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc.
(NASDAQ:ALKS) today announced that a New Drug Application (NDA) for
exenatide once weekly has been submitted to the U.S. Food and Drug
Administration (FDA). Exenatide once weekly is an investigational
sustained release medication for type 2 diabetes that is injected
subcutaneously and administered only once a week. Exenatide is the
active ingredient in BYETTA(R) (exenatide) injection, which is
currently available in the U.S. and in many countries worldwide for
people with type 2 diabetes who are unable to achieve good glycemic
control with common oral therapies. "The exenatide once weekly
submission is an important milestone in the overall exenatide
development program. The clinical data supporting this submission
highlight the potential of exenatide once weekly to significantly
advance the treatment of type 2 diabetes," said Daniel M. Bradbury,
president and chief executive officer of Amylin. "We remain
committed to developing and commercializing a range of treatment
options that address the important unmet needs of people living
with diabetes." Clinical components of the NDA include the
DURATION-1 study and the meta-analysis of primary cardiovascular
events across the BYETTA clinical database. DURATION-1 was designed
to test the superiority of exenatide once weekly, as compared to
BYETTA, which is administered twice daily. In this study, exenatide
once weekly treatment resulted in statistically significant
reductions in A1C of 1.9 percentage points from baseline, compared
to a reduction of 1.5 percentage points for BYETTA, and 77 percent
of patients treated with exenatide once weekly achieved an A1C of 7
percent or less compared to 61 percent of patients treated with
BYETTA. Exenatide once weekly and BYETTA were both associated with
an average weight loss of 8 pounds from baseline. The most commonly
reported adverse event was nausea, which was typically mild and
transient and occurred less frequently in the exenatide once weekly
patients. In addition, a meta-analysis across controlled clinical
studies of three months or greater from the BYETTA database showed
no increased risk of cardiovascular events associated with
exenatide use. This analysis applied principles outlined in the
FDA's guidance for evaluating cardiovascular risk in type 2
diabetes agents. Components of the submission supporting product
manufacturing include analyses to demonstrate comparability of the
intended commercial product with that used during development.
These analyses include data from patients in the ongoing extension
of the DURATION-1 study who used exenatide once weekly produced at
Amylin's manufacturing facility in Ohio. "If approved, exenatide
once weekly would be the first and only once-a-week therapy for the
treatment of type 2 diabetes," said David Vondle, exenatide global
brand development leader for Lilly. "A new treatment option to help
patients with type 2 diabetes manage blood sugar, with potential
weight loss and less frequent dosing, could offer an important
advance in the treatment paradigm for patients and physicians who
manage this chronic condition." About Diabetes Diabetes affects
more than 23 million people in the U.S. and an estimated 246
million adults worldwide.(i,ii) Approximately 90-95 percent of
those affected have type 2 diabetes. Diabetes is the fifth leading
cause of death by disease in the U.S. and 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 support that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi,vii) About BYETTA(R)
(exenatide) injection BYETTA is the first and only FDA-approved
incretin mimetic 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 and low
incidence of hypoglycemia when used 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 BYETTA improves glucose
(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, 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 the most common side effect 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 of 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 full prescribing information, visit
http://www.byetta.com/. About Amylin, Lilly and Alkermes Amylin,
Lilly, and Alkermes are working together to develop exenatide once
weekly, a subcutaneous injection of exenatide for the treatment of
type 2 diabetes based on Alkermes' proprietary technology for
long-acting medications. Exenatide once weekly is not currently
approved by any regulatory agencies. Amylin Pharmaceuticals is a
biopharmaceutical company committed to improving lives through the
discovery, development and commercialization of innovative
medicines. 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. 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 healthcare professionals improve the lives of people with
diabetes, and research continues on innovative medicines to address
the unmet needs of patients. 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. Alkermes, Inc. is a fully integrated biotechnology
company committed to developing innovative medicines to improve
patients' lives. Alkermes' robust pipeline includes
extended-release injectable, pulmonary and oral products for the
treatment of prevalent, chronic diseases, such as central nervous
system disorders, addiction and diabetes. Headquartered in
Cambridge, Massachusetts, Alkermes has research facilities in
Massachusetts and a commercial manufacturing facility in Ohio. This
press release contains forward-looking statements about Amylin,
Lilly and Alkermes and the investigational drug, exenatide once
weekly. 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 approval
of exenatide once weekly and the revenues generated from BYETTA
and/or exenatide once weekly may be affected by competition;
unexpected new data; safety and technical issues; pre-clinical
trial results; clinical trials, including the clinical trials
mentioned in this press release, not being completed in a timely
manner, not confirming previous results, or not achieving the
intended clinical endpoints; the DURATION-1 study extension results
potentially not being accepted to support comparability; label
expansion requests or NDA filings, including the NDA filing
mentioned in this press release, not being submitted and/or
accepted in a timely manner; regulatory approval being delayed or
not received; or manufacturing and supply issues. The potential for
BYETTA and/or exenatide once weekly 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, Lilly and/or
Alkermes. These and additional risks and uncertainties are
described more fully in Amylin's, Lilly's and Alkermes' most recent
SEC filings including their Quarterly Reports on Form 10-Q and
Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake
no duty to update these forward-looking statements. P-LLY (i) "All
About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed March 28,
2009. (ii) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed March 28, 2009. (iii) "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 March 28, 2009. (iv) 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. (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. 2008;31 Suppl 1:S61-78. (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. DATASOURCE: Amylin Pharmaceuticals, Inc.
CONTACT: Anne Erickson of Amylin Pharmaceuticals, Inc.,
+1-858-754-4443, or cell, +1-858-349-3195, ; or Kindra Strupp of
Lilly, +1-317-277-5170, or cell, +1-317-554-9577, ; or Rebecca
Peterson of Alkermes, +1-617-583-6378, or cell, +1-617-899-2447,
Web Site: http://www.amylin.com/ http://www.byetta.com/
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