TOKYO and INDIANAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- The U.S. Food and
Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9
to 0 that prasugrel, an investigational antiplatelet agent, should be approved
for the treatment of patients with acute coronary syndromes (ACS) managed with
an artery-opening procedure known as percutaneous coronary intervention (PCI),
Daiichi Sankyo Company, Limited, (TSE: 4568), and Eli Lilly and Company (NYSE:
LLY) announced today.
The Advisory Committee voted unanimously that prasugrel should be approved
for the treatment of patients with acute coronary syndromes undergoing PCI.
The FDA is not bound by the committee's recommendation, but it takes its
advice into consideration when reviewing new drug applications.
"We are very proud of the prasugrel data," said John Alexander M.D.,
M.P.H., global head of research and development, Daiichi Sankyo Company,
Limited. "Today's scientific exchange set the stage for a potential FDA
approval of prasugrel, and the future availability of this significant
scientific advancement for the treatment of ACS-PCI patients."
"We will continue to work closely with the FDA as the agency moves toward
an action on the new drug application for prasugrel," said J. Anthony Ware,
M.D., Lilly vice president and cardiovascular/acute care platform leader for
prasugrel. "It is important for patients to have multiple treatment options,
and currently, ACS patients undergoing PCI have few options. Today's vote by
the advisory committee members is a positive step for patients."
"Prasugrel represents an important new option for patients with ACS who
are managed with PCI," said lead TRITON-TIMI 38 investigator Elliott Antman,
M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's
Hospital (BWH) in Boston and senior investigator with BWH's TIMI Study Group.
"In a large head-to-head trial, TRITON, showed that prasugrel was superior to
clopidogrel, the current standard of care. While the benefit of prasugrel is
accompanied by an increased risk of serious bleeding events, appropriate
selection of patients and doses may help mitigate this risk."
The committee reviewed comprehensive data primarily from the TRITON TIMI-
38 clinical trial. Results from the TRITON trial showed that prasugrel taken
with aspirin reduced the relative risk of the combined endpoint of
cardiovascular death, non-fatal heart attacks or non-fatal stroke by 19
percent more than clopidogrel (Plavix(R)/Iscover(R)) taken with aspirin. These
benefits were accompanied by an increased risk of serious bleeding with
prasugrel overall, some of which included life-threatening and even fatal
bleeding. When the risk of this type of bleeding was compared to the benefit
of reduced heart attack, there were five more TIMI major bleeding events, but
22 fewer heart attacks for every 1,000 patients treated with prasugrel
compared to every 1,000 patients treated with clopidogrel.(i) The overall risk
of cardiovascular death and the risk of increased stroke were not
statistically different between treatment groups.
FDA reviewers will consider the panel's favorable recommendation in its
review of the new drug application that Lilly submitted for prasugrel on
behalf of the alliance with Daiichi Sankyo, Limited, on December 26, 2007.
The Burden of Acute Coronary Syndromes
Acute coronary syndromes (ACS), which includes heart attack and unstable
angina (chest pain), affects more than 1.4 million people in the United States
annually.(ii) Coronary heart disease, which can result in ACS, is the single
most common cause of death in the European Union, accounting for more than
741,000 deaths in the EU each year.(iii) 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.(iv)
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 syndromes 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 Company, 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 Parsippany, New Jersey, is the U.S.
subsidiary of Daiichi Sankyo Company, 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
Indianapolis, Ind., Lilly provides answers - through medicines and information
- for some of the world's most urgent medical needs.
Plavix(R)/Iscover(R) is a registered trademark of Sanofi Aventis Corp.
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20060314/LILLYSANKYOLOGO )
(i) Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in
Patients with Acute Coronary Syndromes. New England Journal of Medicine.
November 2007; 357: 2001-15.
(ii) American Heart Association. Heart Disease and Stroke Statistics -
2008 Update. Dallas, TX. American Heart Association. (Pg. 14)
(iii) 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 April 24 2008.
(iv) WebMD Medical Reference in Collaboration with the Cleveland Clinic.
Heart Disease: Coronary Artery Disease. June 2004.
