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Daiichi Sankyo, Lilly Obtains FDA Approval For Effient

Effient, for the treatment of percutaneous coronary intervention

Daiichi Sankyo and Eli Lilly have received approval for Effient (prasugrel) tablets from the FDA, for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed a percutaneous coronary intervention (PCI).

Effient helps keep blood platelets from sticking together to form clots.

The company said that Effient should be initiated with a dose of 60mg followed by a maintenance dose of 10mg once daily. In addition, for those patients who weigh less than 132 pounds, physicians should consider lowering the maintenance dose to 5mg once daily. Patients taking Effient should also take 75mg to 325mg aspirin orally once daily, according to their doctors’ instructions.

John Lechleiter, Chairman and CEO of Eli Lilly, said: “The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes.”

“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,” he added.