(Reuters) – The European Commission has granted Amarin Corporation Plc’s fish-oil derived heart drug Vazkepa marketing authorization in the European Union, the drugmaker said on Tuesday.
The authorization allows Amarin to market Vazkepa – sold in the United States as Vascepa – as a treatment to help reduce strokes, heart attacks and other major cardiovascular events in high-risk patients across Europe, the company said.
Vazkepa won U.S. approval in 2012 to lower high triglycerides – a type of blood fat that can increase the risk of heart disease. In December 2019, U.S. health regulators approved expanding the drug’s label to include its heart benefit claims.
(Reporting by Vishwadha Chander in Bengaluru; Editing by Rashmi Aich)