Lilly submits prasugrel NDA

Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. In a recent study [1] prasugrel was more efficient than Plavix at reducing the number of heart attacks and other significant events. However, an increased number of bleeding incidents among the prasugrel group cast a shadow [2]over the results. 1.7 percent of patients taking Plavix experienced serious bleeding incidents, compared to 2.2 percent of prasugrel patients.

FDA approval is crucial for Lilly; analysts say the company has no other blockbuster hopefuls in its pipeline [3], and patent expirations could eat away at 60 percent of its revenue in the coming years. The hope is that the FDA thinks prasugrel's benefits outweigh the increased bleeding risk. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008," said one Lilly VP. If approved, the drug will be marketed under the name Effient.

- check out this release [4] for more
- read this article [5] from Forbes

ALSO: TAP Pharmaceutical has submitted an NDA for TAK-390MR for the treatment of acid related diseases. Release [6]

PLUS: Takeda has submitted an NDA for its type 2 diabetes drug alogliptin. Release [7]

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report [1]
Doubters see big obstacles for Lilly's prasugrel. Report [2]
Lilly suspends dosing in crucial drug trial. Report [8]
Lilly pits drug against Plavix in trial. Report [9]