The US FDA granted a Fast Track designation for Schering-Plough's investigational cardiovascular drug, SCH 530348 .
The FDA granted Fast Track designation for the following reasons:
- Cardiovascular disease, as evidenced in patients with acute coronary syndrome or in patients with a history of major cardiovascular disease, is a serious, life-threatening disease;
- A drug to reduce cardiovascular morbidity and mortality addresses an unmet medical need.
The compound, an oral thrombin receptor antagonist, is currently under Phase 2 clinical trials 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. This fast track status hopes to expedite its product development.
[Source: Schering-Plough]
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