U.S. FDA Grants Priority Review for Vascepa® (Icosapent Ethyl) Supplemental New Drug Application Seeking Cardiovascular Risk Reduction Indication
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- PDUFA date assigned is September 28, 2019, four months sooner than
expected
- Vascepa, assuming approval, will be first drug indicated to reduce
residual cardiovascular risk in patients with statin-managed LDL-C
cholesterol, but persistent elevated triglycerides, as studied in the landmark
REDUCE-IT™ cardiovascular outcomes study