Lilly, Daiichi seek FDA approval of clot drug
NEW YORK (Reuters) - Eli Lilly & Co <LLY.N> and Japan's Daiichi Sankyo Co Ltd <4568.T> said on Friday they had asked U.S. regulators to approve prasugrel, a blood clot preventer that is the U.S. drug maker's most important experimental product.
The companies submitted an application to the U.S. Food and Drug Administration on December 26 and plan to submit one in Europe during the first quarter, they said.
Mixed trial data on the pill were unveiled in November among heart patients slated to receive stents -- tiny devices that prop open coronary arteries that have been cleared of plaque.
Prasugrel was tested in a big trial against Plavix, a blockbuster blood clot preventer sold by Bristol-Myers Squibb Co <BMY.N>. Both treatments stop blood cells called platelets from clumping together.
In that study, prasugrel was 19 percent more effective in preventing cardiovascular death, nonfatal heart attacks and strokes than Plavix, but caused a significantly higher amount of serious bleeding.
"We think it highly likely prasugrel will be approved and that it will raise the bar in anti-platelet therapy," said Anthony Ware, a senior Lilly research executive.
Some industry analysts have predicted U.S. marketing approval for prasugrel, despite the mixed results.
But others expect approval to be delayed until Lilly completes another Phase III trial, involving 10,000 heart patients not slated to receive stents. They caution that prasugrel sales could be limited unless the drug shows more compelling results -- effectiveness without more serious bleeding -- in the new study.
If approved in the United States, the trade name for prasugrel would be Effient.
Lilly shares were down 81 cents, or 1.5 percent, at $52.18 in morning New York Stock Exchange trading amid a sharp downturn in the broad stock market.
(Reporting by Ransdell Pierson in New York and Debra Sherman in Chicago; Editing by Lisa Von Ahn)