Investors in Eli Lilly and Co. showed displeasure this morning in the decision announced late yesterday that the U.S. Food and Drug Administration will extend its review of Lilly’s prasugrel drug by three months.
Shares in the Indianapolis pharmaceutical company fell 2 percent, to $46.63 – a 52-week low.
The FDA’s decision on the highly anticipated blood thinner now won’t arrive until Sept. 26.
The FDA is taking more time, Lilly said, because of “supplemental information” provided to regulators during their review of prasugrel. The agency began a priority review of prasugrel in February.
Lilly, which developed prasugrel with Japan-based Daiichi Sankyo Co. Ltd., hopes the blood thinner can replace Plavix as the leading drug for patients with serious heart problems. Plavix, made by Bristol-Myers Squibb Co. and Sanofi-Aventis, racked up $8.5 billion in sales last year.
In heart patients who have received stents to open their arteries, prasugrel reduced the rate of heart attacks, strokes and heart-related deaths by 19 percent, in a head-to-head study against Plavix. But prasugrel also caused higher rates of bleeding in some patients. Some analysts fear the FDA will require Lilly to conduct more clinical trials before approving prasugrel.
Lilly and Daiichi announced today that they have launched a new clinical trial to compare prasugrel with Plavix in patients who have not received stents. The new study will include 10,000 patients.