Eli Lilly and Daiichi Sankyo report ‘elation’ following prasugrel submission

Eli Lilly and Daiichi Sankyo have announced their happiness and confidence with the submission of prasugrel to the regulatory authorities for approval.

The firms have submitted a new drug application for the compound with the US Food and Drug Administration (FDA) as a treatment of patients with acute coronary syndrome managed with percutaneous coronary intervention, such as coronary stenting.

A number of clinical trials preceded this application, including the landmark Triton-Timi 38 study, which compared the safety and efficacy of the drug with clopidogrel in reducing the incidence of cardiovascular death, non-fatal heart attack, non-fatal stroke and other ischemic events.

If approved, the compound will be known in the US under the trade name of Effient.

J Anthony Ware, vice-president and cardiovascular and acute care platform leader for prasugrel at Eli Lilly, said: “We are elated. 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.”

He added that the benefit/risk profile of the drug could potentially improve clinical outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention.

In November 2007, Eli Lilly announced the results of a phase III clinical study showing the statistical superiority of prasugrel when compared to clopidogrel for this indication.