Expanded use of Medicines blood thinner rejected

Medicines Co. said Wednesday the Food and Drug Administration rejected its application to expand use of its blood thinner Angiomax to include acute coronary syndromes in emergency rooms.

The agency issued a "not approvable" letter due to concerns about the appropriateness of the company's use and interpretation of trial results. The drug is currently approved to reduce the risk of blood clots in adults with chest pain who are undergoing surgery to open blocked cardiac arteries.

Medicines Co. said that trials indicated the use of Angiomax is similarly effective to rival blood thinner heparin, but results in less bleeding and lower costs.

The company said it disagrees with the agency's decision and is in discussions with the FDA to address its concerns.

Despite the FDA's action, Medicines reaffirmed its outlook for 2008 U.S. Angiomax sales between $310 million and $320 million.

Shares of Medicines Co. fell $1.12, or nearly 6 percent, to $18.82 in morning trading.