PARSIPPANY, N.J. and INDIANAPOLIS, Aug. 5 /PRNewswire-FirstCall/ -- Effient(TM) (prasugrel), a new antiplatelet medicine, is now available in pharmacies across the United States, Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY) announced today.
The U.S. Food and Drug Administration approved Effient tablets on July 10 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.
"Before Effient was available, physicians and patients had limited antiplatelet therapy options. Effient is a new treatment option to help reduce an ACS patient's risk of having a heart attack or stent thrombosis after PCI," said Dr. Dean Kereiakes, medical director at The Christ Hospital Heart and Vascular Center in Cincinnati, OH. "Different patients respond differently to medications, so it's important to have multiple options for treating heart disease given how pervasive and costly this condition is in our society."
Effient helps keep blood platelets from clumping together and developing a blockage in an artery. Taking Effient along with aspirin after PCI has been shown to reduce the chances of having a cardiac event such as a heart attack or stent-related blood clots in patients with ACS. Bleeding is the most common side effect of Effient. Some bleeding can be life-threatening, and even fatal.
"We are excited about bringing Effient, to patients and their healthcare professionals," said Enrique Conterno, president of Lilly USA, LLC. "We will work closely with healthcare professionals to ensure they understand how Effient works and who the appropriate patients are to receive this innovative treatment."
"We recognize the need for practical patient support and education during this difficult time in patients' lives, following a major cardiovascular event and possibly having a stent placed in an artery," said Joe Pieroni, president and chief executive officer for Daiichi Sankyo, Inc. "We are dedicated to developing highly relevant, evidence-based programs to help patients recover as well as regain their health and confidence."
Important Safety Information about Effient
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 (eg, warfarin) or taking NSAIDs (eg, 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.
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.
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.
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, including the risk of side effects and other safety concerns. There is no guarantee that the product will continue 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.
Effient(TM) is a trademark of Eli Lilly and Company.
P-LLY
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