Which way, FDA? – Effient Blood Thinner

In addition, the drug makers are facing potential competition with devices that can do the same, but they appear to be surgery related and not for long term use thus far. The device is designed to serve as an alternative to the anticoagulants used to prevent thrombosis during surgery, so no drugs. BD

COMING SOON!" blares the big-type advertisement for Eli Lilly and Co.'s latest-stage pipeline drug, a blood thinner called Effient. But will it be soon enough? The full-page ad appeared in medical journals in June. But just days later, federal regulators said they would need three more months to review tens of thousands of pages of clinical data on the blood thinner. This delayed the launch of Lilly's most anticipated new drug in years. Every month of delay is costing Lilly and its Japanese partner, Daiichi Sankyo, millions of dollars in lost sales. But it also could help regulators identify important safety issues with the drug.

The patents on Lilly's five top-selling drugs will expire beginning in 2011, and the company views the blood thinner as a key way to replace its declining revenue base over the next decade.