HLS Therapeutics Approval for Vascepa ® from Health Canada to reduce the risk of cardiovascular events

HLS Therapeutics Approval for Vascepa ® from Health Canada to reduce the risk of cardiovascular events

HLS Therapeutics Inc., a specialty pharmaceutical company focusing on the central nervous system and cardiovascular markets, is pleased to announce that Health Canada has approved the use of Vascepa ® to reduce the risk of cardiovascular events in high-triglyceride statin-treated patients at high risk of cardiovascular events due to cardiovascular disease or diabetes.

“Cardiovascular disease is the world’s leading cause of death and Vascepa presents healthcare providers with a new treatment alternative to improve cardiovascular safety for many Canadians at risk of a heart attack,” said Dr. Jean-Claude Tardif, a cardiologist and head of the research center of the Montreal Heart Institute.

In the worldwide review of REDUCE-IT ® cardiovascular results, nearly 28% of patients in the control arm treated with statins and other contemporary treatment but not treated with Vascepa had a significant adverse cardiovascular condition, identified as the first instance of either myocardial infarction, stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascularization.

As evidenced by this occurrence of MACE, there is a group of patients who continue to have a high need for additional cardiovascular preventive care despite controlling their cholesterol on statin therapy.

For those adult patients in this category with elevated serum triglyceride levels and cardiovascular disease or diabetes and at least one additional risk factor in cardiovascular disease, Vascepa shows a 25% decrease in the risk of major adverse cardiovascular events at first and is the first drug approved to help reduce this chronic cardiovascular risk.

Vascepa’s approval is supported by data from REDUCE-IT ® 2, a 2018 analysis of 8,179-patient cardiovascular outcomes.

REDUCE-IT was the first international review of cardiovascular outcomes to determine the efficacy of pure and effective EPA treatment as an add-on to statins in patients with increased cardiovascular risk who had elevated serum triglyceride rates following successful statin therapy.

In December 2019, the U.S. Food and Drug Administration approved the use of Vascepa tablets to reduce cardiovascular risk.