Prasugrel Doc Urges FDA to Nix Approval for Lilly Drug

(MoneyWatch)  Just when Eli Lilly CEO John Lechleiter thought he was out of the woods on prasugrel/Effient -- he got a unanimous approval vote from an FDA panel in February -- comes a letter to the FDA from the guy who invented the drug that says it causes bleeding and cancer.

BNET has previously noted that Lilly really, really needs to get this drug to market. Not only has the company not launched a new drug since Byetta in 2005, but it acquired ImClone in part as a hedge against the FDA not approving prasugrel. You can tell Lilly is desperate to get the FDA approval because it has already been advertising the drug on medical websites (see image of banner ad).

The letter, from Dr Victor Serebruany (Johns Hopkins University, Baltimore, MD), is the latest in a chain of stumbles along the FDA approval path for prasugrel. In February, Dr. Sanjay Kaul was bounced from the FDA's prasugrel panel after Eli Lilly called the FDA to question his inclusion. Kaul had questioned Lilly's data on the drug. The FDA later admitted the removal of Kaul was a "mistake."

Now take a close look at the Serebruany letter (as wrangled by Public Citizen and Dr. Sydney Wolfe). It's got three media-friendly subheds: Wrong dose studied! Bleeding and cancer! Efficacy claims suspect!

Even if prasugrel is approved, Bristol-Myers Squibb -- which markets the dominant brand, Plavix -- couldn't have asked for a more problematic launch.

Heartwire has a nice list of links to detailed coverage of this issue:

• See BNET's previous coverage of Eli Lilly and prasugrel:
• Lilly Advertises "Effient" Despite Lack of FDA Approval
• FDA's Prasugrel Machinations Seem Bound to Attract Doubt
• Lilly CEO Lechleiter's Prasugrel Bet Appears to Pay Off
• Odds Improve for Lilly's Prasugrel-ImClone Gamble
• In Light of Prasugrel Delay, Lilly-ImClone Deal Suddenly Makes Sense
• More Bad News for Lilly's Prasugrel