(Adds CEO quote, details of Europe approval and drug, background on U.S. approval)
March 30 (Reuters) - Amarin Corporation Plc said on Tuesday that the European Commission has granted its fish-oil derived heart drug Vazkepa a marketing authorization in the European Union.
The authorization allows Amarin to market Vazkepa, which is 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, a highly purified form of omega-3 fatty acid, 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 here expanding the drug's label to include its heart benefit claims, opening a multibillion-dollar market opportunity for the company.
The European Commission in its marketing authorization identified Vazkepa as a new active substance, echoing the positive opinion of the European Medicines Agency (EMA), when it recommended here the authorization in January this year.
The European approval provides 10 years of market protection for Vazkepa in the European Union, John Thero, Amarin’s president and chief executive officer, said in a statement. (Reporting by Vishwadha Chander in Bengaluru; Editing by Rashmi Aich)