EMA reviewing marketing application for Vascepa
The European Medicines Agency has begun its review of a marketing application for Vascepa (icosapent ethyl), from USA-based cardiovascular specialist Amarin (Nasdaq: AMRN).
Approval would allow marketing to reduce the risk of cardiovascular events in high-risk patients on standard-of-care statin therapy, an indication in which the firm recently filed for approval in the USA.
While the therapy has been approved in the USA to reduce triglycerides since 2012, it has not been approved in any indication in Europe.
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