More Bad News for Lilly's Prasugrel

(MoneyWatch)  The bleeding risks of Eli Lilly's new blood thinner, prasugrel, are less clear than the company thinks, according to a Cedars Sinai cardiologist. The drug -- which Lilly hopes will be huge -- is currently under review by the FDA but has suffered a series of delays that have set back its expected approval date by months. The news adds to the suggestion that Lilly's acquisition of ImClone may have been driven in part by the company's assumption that there was a good chance the FDA will not ultimately approve prasugrel (pictured).

Reuters reports:

Researchers of the Lilly-sponsored trial had theorized that prasugrel could be safely given, as long as it was not taken by three groups shown to have the highest bleeding risk in the trial: patients weighing less than 130 pounds, those aged 75 or older, or those who had previous strokes or so-called mini-strokes.

But Dr. Sanjay Kaul, a cardiologist with Cedars-Sinai Heart Institute in Los Angeles, said on Monday that theory was at odds with scientific facts...

Kaul said the risk of serious bleeding in the supposedly high-risk patients was 42 percent higher than with Plavix, compared with 24 percent higher risk among other patients receiving prasugrel.

Although the bleeding risk for the "high-risk" groups was numerically higher than for the "non-high risk" patients taking prasugrel, it was not statistically significant, he said in an interview.

"So you cannot identify which patients should be excluded," he said, adding that too few patients were tested in Triton to draw any firm conclusions about which groups were at greater or lesser bleeding risk.

In Triton, prasugrel was 19 percent more effective than Plavix in preventing cardiovascular death, nonfatal heart attacks and strokes. But it was 32 percent more likely to cause serious bleeding.

Although a number of drugs are delayed in the FDA's approval process, the drumbeat of bad news surrounding prasugrel should not be a surprise to BNET readers. We noted a month ago that Lilly's recent behavior -- such as acquiring ImClone -- suggests that CEO John Lechleiter may already have concluded that there's a good chance prasugrel won't make it to market.

(Back story: Lilly hasn't had a new drug approved for three years, bleeding cases associated with prasugrel have been popping up since last September; and although some think Lilly overpaid in the ImClone deal, having the cancer company's pipeline will fill the hole made by prasugrel if the FDA says no.)