The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of icosapent ethyl to reduce the risk for cardiovascular (CV) events in patients at high CV risk.
The marketing authorization for icosapent ethyl, under the brand name Vazkepa, is expected to be in statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes with at least one CV risk factor, Amarin said in a release today.
The high-dose eicosapentaenoic acid preparation was approved in the United States, under the brand name Vascepa, for the treatment of elevated triglycerides in 2012 and for CV risk reduction in adults like those in the CHMP recommendation in December 2019.
Both the 2019 approval and the CHMP recommendation were based in part on results from the REDUCE-IT trial, which reported a 25% relative risk reduction in major adverse CV events in the high-risk patients compared with a placebo-control group.
“Ten years of market protection is expected to be granted in the EU as part of a European Commission approval of the pending application,” Amarin said. “In addition, pending patent applications related to the REDUCE-IT study have the potential to extend exclusivity in Europe into 2039.”
The CHMP’s recommendation will now be considered by the European Commission, with a decision expected within 67 days.