One of the doctors involved in an early clinical study of Eli Lilly's prasugrel, a potential blockbuster and one of the company's biggest new drug prospects, has joined with two consumer advocates at Public Citizen to call on the FDA to halt its ongoing review of the anti-clotting drug and force the company to mount new studies on a lower dose of the drug.
Johns Hopkins University's Victor Serebruany says that the 10 mg dose of prasugrel spurs the risk of major bleeding and may promote the development of cancer. "While prasugrel does not appear to be a carcinogen, it may act as a cancer promoter through its excessive antiplatelet activity, diminishing the natural capacity of platelets to halt the spread of locally-confined or "silent" tumors," wrote the doctors.
They added: "Current data are insufficient to demonstrate its safety and efficacy for use in ACS, and we urge the FDA to immediately halt review of this drug until a new Phase 3 study can be conducted with an appropriate lower dose of prasugrel and properly defined outcomes." The doctors want the developers to study a 5 mg dose. Lilly says a study of a lower dose is underway but won't be completed before 2011, according to Dow Jones.
Just last February an FDA panel voted to recommend the application for prasugrel, which is being advanced by Lilly and Daiichi Sankyo. Serebruany raised his concerns with the panel before the vote was taken. And both companies have invested heavily in the program, recruiting 13,000 patients for one study that found prasugrel was better than Plavix at preventing blood clots but was also associated with a higher risk of bleeding.
- read the report from Dow Jones
- read the letter