The FDA has approved the NDA by Daiichi Sankyo and Eli Lilly and Co. for 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 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, according to a Daiichi statement.

“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 Lilly. “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.”

In trials, Effient demonstrated a risk “significant, sometimes fatal bleeding,” according to the FDA, so the drug will contain a “black box” warning.

The risk of bleeding was highest in patients who were either 75 years of age or older, weighed less than 132 pounds, 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.

The approval came 18 months after submission, and involved some controversy around the FDA’s advisory panel. The drug is expected to compete with Plavix, the blockbuster marketed in the U.S. by Bristol-Myers Squibb.