EMA accepts for review marketing authorisation application for Amarin's icosapent ethyl (Vascepa) for reduction of cardiovascular risk in high-risk patients, as reflected in REDUCE-IT study

Amarin Corporation

2 December 2019 - Amarin Corporation announced today that the EMA has validated the marketing authorisation application seeking approval for icosapent ethyl (brand name Vascepa in the United States) as a treatment to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment, but have elevated triglycerides, 135 mg/dL or above, and other cardiovascular risk factors. 

The validation confirms the submission for Vascepa is sufficiently complete for the EMA to begin its review procedure, which is currently expected to be completed before the end of 2020.

Read Amarin Corporation press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier