Date: November 18, 2009
Refer to: Tammy Hull
Eli Lilly and Company
317-651-9116 (office)
317-614-5132 (cell)
Kimberly Wix
Daiichi Sankyo (U.S.A.)
973-944-2338 (office)
908-656-5447 (cell)
Shigemichi Kondo
Daiichi Sankyo (Tokyo)
81-3-6225-1126 (office)
New Updates to AHA/ACC/SCAI Clinical Guidelines Recommend Treatment with
Effient® for Patients with Acute Coronary Syndromes Managed with PCI
PARSIPPANY, NJ AND INDIANAPOLIS, Ind. (November 18, 2009) - Effient®
(prasugrel) tablets, a new antiplatelet medicine, was added as a treatment
option in two clinical guideline updates: one for patients receiving
percutaneous coronary intervention (PCI) and a second one for patients with ST
elevation myocardial infarction (STEMI), or severe heart attack. The two 2009
focused updates for the clinical guidelines, jointly developed by the American
Heart Association (AHA), the American College of Cardiology (ACC), and the
Society for Cardiovascular Angiography and Interventions (SCAI), were published
online today in Circulation, the Journal of the American College of Cardiology
and Catheterization and Cardiovascular Interventions.
Approved by the U.S. Food and Drug Administration in July 2009, Effient is
indicated to lower the chance of having another thrombotic cardiovascular event
such as heart attack or stent-related blood clot for patients with acute
coronary syndromes (ACS) who are managed with angioplasty and stenting, also
known as PCI.
Effient received the Class I recommendation from the Guidelines Committee in
both sets of the guideline updates. Class I means that a given "procedure/
treatment should be performed/administered" to patients, given it was found to
be "useful/ effective/beneficial". Consistent with the Effient label, both
guidelines provide recommendations to avoid the use of Effient in patients with
a prior history of TIA or stroke.
"It is important that the cardiology community has updated clinical guidelines
that include the latest treatment options like Effient for treating ACS
patients managed with angioplasty and stenting," said LeRoy LeNarz, M.D.,
senior medical director of cardiovascular care, Lilly USA, LLC. "By
recommending Effient, these guidelines recognize an important new treatment for
ACS-PCI patients, particularly for those with severe heart attacks who are at
increased risk of suffering future cardiovascular events."
"The Guidelines Committee classified prasugrel, marketed in the United States
as Effient, with a Class I rating," said Rogelio Braceras, M.D., senior medical
director for Daiichi Sankyo, Inc. "Based on the latest clinical studies and
scientific evidence, these guidelines provide clear recommendations for how
Effient should be incorporated into medical practice to help reduce risk of
cardiovascular events such as heart attacks and blood clots forming around
stents."
About Effient
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE:
LLY) co-developed Effient, an oral antiplatelet agent discovered by Daiichi
Sankyo and its Japanese research partner, Ube Industries, Ltd. Effient helps
keep blood platelets from clumping together and developing a blockage in an
artery. Effient is approved by the U.S. Food and Drug Administration for the
reduction of thrombotic cardiovascular events (including stent thrombosis) in
patients with acute coronary syndromes (ACS) who are managed with an
artery-opening procedure known as percutaneous coronary intervention (PCI). PCI
usually includes the placement of a stent to help keep the artery open.
Important Safety Information about Effient
Patients should not stop taking Effient without first talking to the doctor who
prescribed it for them, as this may result in increased risk of a clot in their
stent, a heart attack or death.
Patients should get medical attention right away if they develop any of the
following unexpected symptoms: fever, weakness, yellowing of the skin or eyes,
or if skin becomes very pale or dotted with purple spots. These symptoms may be
signs of a rare but potentially life-threatening condition called TTP, which
has been reported with other medicines in this class that are like Effient,
sometimes after a short time (less than 2 weeks).
For more information about Effient including prescribing information, please
visit www.Effient.com.
About Daiichi Sankyo
A global pharmaceutical 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. Areas of primary focus for Daiichi Sankyo 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 Co., Ltd. For more information on Daiichi Sankyo,
Inc., please visit www.dsi.com.
About Eli Lilly and Company
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, Ind., Lilly provides answers -
through medicines and information - for some of the world's most urgent medical
needs. Additional information about Lilly is available at www.lilly.com.
This press release contains certain forward-looking statements about Effient
for the reduction of thrombotic cardiovascular events (including stent
thrombosis) in patients with acute coronary syndromes who are managed with
percutaneous coronary intervention and reflects Daiichi Sankyo's and Lilly's
current beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development and
commercialization. There is no guarantee that future study results and patient
experience will be consistent with study findings to date or that the product
will 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.
Effient® is a registered trademark of Eli Lilly and Company.
P-LLY
# # #
Antiplatelet medicines, including Effient, can increase the risk of bleeding.
If patients have unexplained or excessive bleeding while on Effient, they
should contact their doctor right away as some bleeding can be serious, and
sometimes may lead to death. Patients should not take Effient if they have a
stomach ulcer or other conditions that cause bleeding or if they have a history
of stroke or "mini-stroke" (transient ischemic attack or TIA).
If patients are 75 or older, or if they weigh less than 132 pounds, or if they
are taking anticoagulants (e.g., warfarin) or taking NSAIDs (e.g., ibuprofen or
naproxen) for a long time, they should talk to their doctor, as they may be at
an increased risk of bleeding.
If patients plan to have surgery or a dental procedure, they should tell their
doctors that they are taking Effient.