FDA e prasugrel

FDA asks panel of heart doctors for help reviewing blood-thinning drug prasugrel.
The Wall Street Journal (1/2, Rockoff, subscription required) reports that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee is set to meet on Feb. 3, and while details of the panel's agenda were not available, Eli Lilly and partner Daiichi Sankyo say that the body will discuss "whether to finally approve prasugrel," the company's "powerful anti-clotting drug and would-be competitor to blockbuster Plavix. ... Early this year, lots of folks were brimming with anticipation for prasugrel, a more powerful clot-fighter than Plavix. But the Lilly medicine also carried a higher risk for life-threatening bleeding. Perhaps no surprise then that there was a three-month delay in FDA's review earlier this year, then another with a less clear timetable for action, as the agency weighed what to do." The Journal predicts that the drug will soon be on the market in Europe, but expressed doubt that the FDA will automatically follow suit.
The AP (1/2) also reports on the upcoming meeting, noting that prasugrel is "a potential blockbuster drug that has been plagued by regulatory delays." Prasugrel "is considered crucial to Lilly as it faces a wave of patent expirations in the next few years. Lilly previously told investors it expects to begin selling prasugrel in the first half of 2009, but declined to set a specific date for FDA approval."