Eli Lilly and Co.'s frustrating attempt to get a ruling from federal regulators on its experimental blood thinner prasugrel may be a test case of life under a more cautious-and understaffed-U.S. Food and Drug Administration.
That's the opinion taken by many pharmaceutical analysts after the FDA missed its self-imposed Sept. 26 deadline to make a ruling on prasugrel.
The FDA already had delayed its decision by three months after it agreed to give prasugrel a "priority" review lasting six months. Neither FDA nor Lilly gave a new date on which the FDA will rule.
"This has become a bit of an unsettling trend at the FDA," Miller Tabak & Co. analyst Les Funtleyder wrote in a note to investors on Sept. 29. "The decision tree used to be pass or fail. Now there is a third column, the 'I don't know.' If the 'I don't know' actually ensures public health, it would be one thing, but a really unsuitable drug should just be not approved."
Credit Suisse pharmaceutical analyst Catherine Arnold said prasugrel appeared to be "another victim" of staffing constraints at the FDA. Arnold still thinks Lilly will win approval soon for prasugrel, which would be called Effient when sold on the market.
But other analysts still believe the FDA will ask Lilly to provide more data or, worse, conduct another long, expensive clinical trial.
The FDA also could ask for outside medical experts to review Lilly's data and render an opinion.
Lilly can ill afford further delays. It needs to build a market presence for prasugrel before generic versions of its competitor, Plavix, hit the market in 2011.
Plavix, the leading blood thinner, produced $8.5 billion in global sales last year for its makers, New York-based Bristol-Myers Squibb Co. and France-based Sanofi-Aventis.
Lilly would split any sales of prasugrel with its development partner, Japan-based Daiichi Sankyo Co. Ltd. Because of that arrangement, analysts predict Lilly's peak annual revenue from prasugrel at about $2 billion.