U.S. News Room
Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient™...
July 10, 2009
PARSIPPANY, NJ and INDIANAPOLIS, IN (July 10, 2009) – Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Effient™ (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes 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.
Effient (pronounced Ef-fee-ent) helps keep blood platelets from sticking together to form clots, which can block an artery. Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition.
"After more than a decade of research and testing, we are proud to provide this new treatment option to patients with ACS who are managed with PCI," said Takashi Shoda, president and chief executive officer, Daiichi Sankyo Company, Limited. Our Daiichi Sankyo and Lilly alliance will launch Effient in the U.S. in the coming weeks."
"The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes," said John Lechleiter, Ph.D., chairman and chief executive officer of Eli Lilly and Company. "The Daiichi Sankyo/Lilly alliance has provided doctors with an important new option that provides greater protection against thrombotic cardiovascular events to help those suffering with ACS who are being managed with PCI."
Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for those patients who weigh less than 132 pounds (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 mg to 325 mg aspirin orally once daily, according to their doctors' instructions.
"The data from the TRITON-TIMI 38 Phase 3 pivotal trial provide compelling evidence that treatment with prasugrel significantly reduced the combined risk of cardiovascular death, heart attack or stroke over the current standard of care, clopidogrel, across a wide variety of patient types," said lead TRITON-TIMI 38 investigator Elliott Antman, M.D., professor of Medicine at Brigham and Women's Hospital (BWH) in Boston and senior investigator with the BWH TIMI Study Group. "Prasugrel is an important new option for patients with ACS who are managed with PCI. Prasugrel was associated with a significantly higher risk of serious bleeding events compared with clopidogrel. However, appropriate patient selection may help reduce this risk."
The risk of bleeding was highest in Effient-treated patients who were either 75 years of age or older, weighed less than 132 pounds (60 kg), or who had a prior history of transient ischemic attacks (TIA) or stroke. Effient is contraindicated in patients with a history of prior TIA/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of prior heart attack.
ACS, which includes heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually, many of whom are managed with PCI i. In 2009, an estimated 785,000 people in the United States will have a new heart attack and about 470,000 will have a recurrent attack.ii
Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) co-developed Effient, which was discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. (TSE: 4208).
TRITON-TIMI 38 CLINICAL TRIAL
The approval was based on results from the pivotal Phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with Plavix® (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots (known as stent thrombosis) in patients treated with Effient compared with Plavix (a relative risk reduction of approximately 50 percent).
The risk of non-coronary artery bypass graft (non-CABG) related bleeding, which included life-threatening and fatal bleeding, was significantly higher with Effient (2.2 percent) compared with Plavix (1.7 percent). When compared with the overall treatment population, the risk of major bleeding was highest among those patients treated with Effient who were either 75 years or older, had a body weight less than 132 pounds, or had a prior history of transient ischemic attack/stroke.
An analysis from TRITON-TIMI 38, weighing the risk of major bleeding and the reduction in cardiovascular events, found an overall benefit significantly favoring Effient compared with Plavix. For every 1,000 patients treated with Effient as compared with Plavix, there were 23 fewer patients with heart attacks and six more with major bleeding events.
In addition, the results from a pharmacogenetic substudy of TRITON-TIMI 38 patients, as well as several early phase pharmacokinetic studies, showed that the active form of prasugrel does not appear to be affected by genetic variations in common cytochrome P450 (CYP) enzymes, including CYP2C19. Because both Effient and Plavix are "prodrugs", they require CYP450 enzymes to convert them to their active drug form. Approximately 30 percent of Caucasians and 60 percent of Asians have reduced function in the CYP2C19 gene. Many drugs, including certain proton pump inhibitors such as omeprazole, also inhibit CYP2C19iii. As stated in the Plavix prescribing information, studies have shown that formation of clopidogrel's active metabolite may be affected by patients with reduced CYP2C19 function or by drugs that inhibit CYP2C19, including certain proton pump inhibitors such as omeprazole.iv,v
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 shold 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, IN, 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. 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 trademark of Eli Lilly and Company.
Plavix® is a registered trademark of Sanofi-Aventis Corp.
i American Heart Association. Heart Disease and Stroke Statistics – 2008 Update. Dallas, TX. American Heart Association. (Pg. 14)
ii American Heart Association Heart Disease and Stroke Statistics – 2009 Updated. Dallas, TX. American Heart Association. (Pg. 2)
iii Effient Prescribing Information
v Plavix Prescribing Information