Amarin’s Vazkepa Wins European Approval to Treat Heart Disease Risks
The European Commission has granted approval to Amarin’s fish oil drug Vazkepa (icosapent ethyl) for reducing the risk of cardiovascular events in high-risk, statin-treated adults with elevated levels of triglycerides.
The marketing authorization was supported by trial results from more than 8,000 high-risk participants, in which patients treated with statins and Vazkepa showed a 25 percent risk reduction in the first occurrence of a major adverse cardiovascular event, including heart attack or stroke, when compared against placebo during a five-year follow-up period.
The FDA previously approved the therapy to treat cardiovascular risk in December 2019. In the U.S., the drug is sold under the brand name Vascepa.