UK Authorizes Amarin’s Fish Oil Drug Vazkepa
The UK’s Medicines and Healthcare products Regulatory Agency has approved Amarin’s fish oil drug (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adults with elevated levels of triglycerides.
The marketing authorization was supported by phase 3 study results from more than 8,000 high-risk participants, in which those 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 drug received authorization for the same indication in the EU in recent weeks. The FDA approved the therapy to treat cardiovascular risk in December 2019. In the U.S., the drug is sold under the brand name Vascepa.