Circulation Issues

FDA staff backs Medicines Co's once-rejected blood clot preventer

Geralt/Public Domain

 (Geralt/Public Domain )

An intravenous blood clot preventer developed by The Medicines Co should be approved by the U.S. Food and Drug Administration, FDA staff reviewers concluded. 

The injection, cangrelor, which won European approval in March, is designed to prevent blood clots during angioplasty, a procedure to widen narrow or clogged coronary arteries, which often includes the use of stents.

The FDA rejected the blood thinner in April last year and had asked the company to re-analyze data from a pivotal trial, called Champion-Phoenix.

"The Phoenix-study as a stand-alone trial was sufficient to warrant approval of cangrelor," the staff reviewers said in a report published on Monday.