HLS in-licensed the exclusive rights to Vascepa for the Canadian market from
'Cardiovascular disease is the leading cause of death worldwide and Vascepa provides a new treatment option for healthcare practitioners to enhance cardiovascular protection for the many Canadians at risk of a cardiac event,' said Dr.
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 revascularization, unstable angina requiring hospitalization or cardiovascular death.2 As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated serum triglycerides (TG) levels (1.5mmol/L and < 5.6mmol/L) and established cardiovascular disease or diabetes and at least one additional risk factor for cardiovascular disease, Vascepa showed a 25% risk reduction in the first occurrence of major adverse cardiovascular events and is the first drug approved to help reduce this persistent cardiovascular risk in that specified population.
'As approved by
Vascepa is the subject of numerous Canadian issued patents and pending patents with expiration dates which could extend to 2039. The eligible patents will be added to
The approval of Vascepa is supported by data from REDUCE-IT2, an 8,179-patient cardiovascular outcomes study that was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of pure and stable EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated serum triglyceride levels (1.5mmol/L and
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