Exenatide Once Weekly New Drug Application Review Extended By FDA Due to Weather-Related Closure
February 25 2010 - 8:00AM
PR Newswire (US)
SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Feb. 25, 2010
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc.
(NASDAQ:ALKS) today confirmed that the U.S. Food and Drug
Administration (FDA) has set a new Prescription Drug User Fee Act
(PDUFA) action date of March 12 for its review of the exenatide
once weekly new drug application (NDA). The revised action date is
the result of the FDA's decision to allow five additional days for
its review of pending regulatory applications following the
agency's recent five-day weather-related closure. Exenatide once
weekly is an investigational, extended-release medication for type
2 diabetes designed to deliver continuous therapeutic levels of
exenatide in a single weekly dose. The NDA for exenatide once
weekly was submitted in May 2009 and accepted by the FDA in July
2009. Additional information about weather-related delays is
available in a press release on the FDA's Web site:
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm200361.htm.
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 Medisorb® technology for long-acting
medications. Exenatide once weekly is not currently approved by any
regulatory agencies. Amylin Pharmaceuticals is a biopharmaceutical
company dedicated to improving lives of patients 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 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
Waltham, Massachusetts, Alkermes has a research facility in
Massachusetts and a commercial manufacturing facility in Ohio.
Medisorb® is a registered trademark of Alkermes, Inc. P-LLY
DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
CONTACT: Anne Erickson of Amylin, +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,
+1-781-609-6378, or cell, +1-617-899-2447, Web Site:
http://www.amylin.com/
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