Heart drug Efient approved by EMEA

2/24/2009

INDIANAPOLIS The European Medicines Agency has approved a new drug by Eli Lilly & Co. and partner Daiichi Sankyo Co. for preventing heart attacks in patients with acute coronary syndrome undergoing a heart-opening procedure, the two companies announced Monday.

The EMEA approved Efient (prasugrel) for ACS patients undergoing percutaneous coronary intervention surgery following a positive opinion adopted by the EMEA's Committee for Medicinal Products for Human Use.

"This European approval is good news for doctors and patients since more than 700,000 people die from heart attacks in the European Union each year," Daiichi Sankyo president and CEO Takashi Shoda said in a statement. "We believe Efient will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences." 

The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend approval of prasugrel for the United States market on Feb. 3, but the two companies had not decided on a brand name at the time. 

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