Prasugrel given priority review by FDA

WASHINGTON A new drug, prasugrel, manufactured by Eli Lilly and Daiichi Sankyo, has been granted a priority review by the Food and Drug Administration.

The drug is intended for the prevention of blood clots, and if approved, will be competing against Plavix, the blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis. A study conducted in November has already shown that prasugrel was 19 percent more effect than Plavix, but resulted in a higher amount of serious bleeding.

A priority view, according to published reports, means that the FDA will decide within six months whether or not to approve the drug. An approval for a drug usually takes about 10 to 12 months.

The application for prasugrel was filed on December 26, and since the news of its priority view its shares rose up nearly 3 percent. If approved, Lilly plans its drug to be brand named Effient.