Daiichi Sankyo, Inc and Eli Lilly and Company announced that the US 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 US in the coming weeks."
"The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes," said John Lechleiter, 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, 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. 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.
Daiichi Sankyo Company, Limited and Eli Lilly and Company co-developed Effient, which was discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd.