Schering-Plough’s Heart Drug Fast Tracked By FDA

The FDA has granted fast track designation for SCH 530348, Schering-Plough’s investigational oral thrombin receptor antagonist currently in phase II clinical development for secondary prevention of cardiovascular morbidity and mortality outcomes in at-risk patients.

Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions which demonstrate the potential to address unmet medical needs.

An important feature of fast track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor company to improve the efficiency of product development.

Schering-Plough is investigating SCH 530348 for prevention of arterial thrombosis in patients with acute coronary syndrome and those with prior myocardial infarction or stroke, as well as in patients with existing peripheral arterial disease.

Thrombosis may result in partial or complete blockage of critical arteries. This process is the underlying mechanism of most acute vascular events, including acute coronary syndromes (ACS) such as myocardial infarction (MI), and ischemic stroke, which are the leading causes of death.