Posted by Michael Wonder on 02 Jan 2020
HLS Therapeutics announces Health Canada approval for Vascepa to reduce the risk of cardiovascular events
1 January 2020 - Health Canada approval follows priority review for Vascepa.
HLS Therapeutics is pleased to announce that Health Canada has approved the use of Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or hospitalisation for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation in 2017.
In the global REDUCE-IT cardiovascular outcomes study, approximately 28 percent of patients in the control arm treated with statins and other contemporary therapy but not treated with Vascepa experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularisation, unstable angina requiring hospitalisation or cardiovascular death.
