Recently, Eli Lilly & Co.’s (LLY) Effient (prasugrel) received a major boost when it was added as a treatment option in two clinical guideline updates. These were for patients receiving percutaneous coronary intervention (PCI) and for patients with ST elevation myocardial infarction (STEMI), or severe heart attack. The guideline updates have been jointly developed by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI).

Effient, co-developed by Eli Lilly and Daiichi Sankyo of Japan, received the US Food and Drug Administration’s approval in July 2009 to lower the chance of having another thrombotic cardiovascular event (such as heart attack or stent-related blood clot) for patients with acute coronary syndromes (ACS) who are managed with angioplasty and stenting, also known as PCI. PCI usually includes the placement of a stent to help keep the artery open.

In addition, positive data related to Effient’s effectiveness in diabetic patients were presented at the American Heart Association 2009 Scientific Sessions held last month. It was observed that patients with type II diabetes mellitus who also had coronary artery disease (CAD) had significant better results with Effient compared to Plavix (clopidogrel) marketed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY).

The OPTIMUS-3 study was conducted with 35 patients with type II diabetes who also had CAD and were taking aspirin. The study was designed to compare the antiplatelet activity of Effient at standard doses with high doses of Plavix in patients with type II diabetes mellitus who also had CAD. It was observed that within four hours, the level of platelet inhibition with Effient (a 60 mg loading dose) was higher than patients on Plavix (a 600 mg loading dose). However, a 600 mg loading dose of Plavix is not approved for use currently.

With respect to the maintenance dose, Effient also proved its efficacy. After 7 days, results revealed that a 10 mg maintenance dose of prasugrel achieved greater platelet inhibition than a 150 mg maintenance dose of clopidogrel. While this is good news for Lilly, it will be a major concern for both Bristol-Myers and Sanofi if patients switch to their rival drug.

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