FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel
Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today
confirmed that the U.S. Food and Drug Administration’s (FDA) Cardiovascular
and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an
advisory committee hearing on
investigational antiplatelet agent for the treatment of patients with acute
coronary syndromes (ACS) who are being managed with an artery-opening
procedure known as percutaneous coronary intervention (PCI), which is usually
followed by the placement of a stent to help keep the artery open.
Advisory committees provide the FDA with independent advice from outside
medical experts during the review process. The companies will have further
discussions with the FDA in preparation for the Advisory Committee Meeting.
“We welcome the opportunity to discuss any and all of the prasugrel data
with the advisory committee and the agency, just as we have throughout the
ongoing review,” said
development, Daiichi Sankyo Company, Limited.
“We have full confidence in the data submitted to the FDA and the overall
benefit-risk profile of prasugrel, and we look forward to this next step in
potentially bringing an important new alternative to the oral antiplatelet
market,” said
cardiovascular/acute care platform leader for prasugrel.
The Burden of Acute Coronary Syndromes
Acute coronary syndromes (ACS), which is comprised of heart attacks and
unstable angina (chest pain), affects more than 1.4 million people in
United States
is the single most common cause of death in the European Union, accounting for
more than 741,000 deaths in the EU each year.(ii) Coronary artery disease
occurs when the arteries become narrowed or clogged by cholesterol and fat
deposits and cannot supply enough blood to the heart. In some cases, a blood
clot may partially or totally block the blood supply to the heart resulting in
ACS.(iii) Many ACS patients are managed with PCI, which usually includes a
stent placement.
About prasugrel
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company
(NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet
agent discovered by Daiichi Sankyo and its Japanese research partner, Ube
Industries, Ltd., as a potential treatment, initially for patients with acute
coronary syndrome who are managed with PCI. Prasugrel works by inhibiting
platelet activation and subsequent aggregation by blocking the P2Y12 adenosine
diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents
prevent platelets from clumping or sticking together, which can result in
clogged arteries and may lead to heart attack or stroke.
About Daiichi Sankyo
A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in
2005 through the merger of two leading Japanese pharmaceutical companies.
This integration created a more robust organization that allows for continuous
development of novel drugs that enrich the quality of life for patients around
the world. A central focus of Daiichi Sankyo’s research and development are
thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune
disorders. Equally important to the company are hypertension, hyperlipidemia
or atherosclerosis and bacterial infections. For more information, visit
www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in
subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi
Sankyo, Inc., please visit www.dsus.com.
About Eli Lilly and Company
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
information — for some of the world’s most urgent medical needs.
P-LLY
This press release contains certain forward-looking statements about the
potential of the investigational compound prasugrel (CS-747, LY640315) and
reflects Daiichi Sankyo’s and Lilly’s current beliefs. However, as with any
pharmaceutical compound under development, there are substantial risks and
uncertainties in the process of development and regulatory review. There is no
guarantee that the compound will receive regulatory approval, that the
regulatory approval will be for the indication(s) anticipated by the
companies, or that later studies and patient experience will be consistent
with study findings to date. There is also no guarantee that the compound will
prove to be commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly’s filing with the United States Securities
and Exchange Commission and Daiichi Sankyo’s filings with the Tokyo Stock
Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking
statements.
(i) American Heart Association. Heart Disease and Stroke Statistics -
2008 Update.
(ii) British Heart Foundation Health Promotion Research Group. European
Cardiovascular Disease Statistics 2008,
http://www.ehnheart.org/content/ItemPublication.asp?docid=7069&level0=1500&lev
el1=2157, Accessed
(iii) WebMD Medical Reference in Collaboration with the Cleveland Clinic.
Heart Disease: Coronary Artery Disease.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO)
SOURCE Eli Lilly and Company