European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS)​ Incorporate Findings From Amarin's REDUCE-IT Cardiovascular Outcomes Study into Practice Guidelines

Posted on September 03, 2019 by Medtech[y] Staff

Over the weekend, the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) updated their Clinical Practice Guidelines for the Management of Dyslipidaemias by incorporating findings from Amarin's REDUCE-IT cardiovascular outcomes study.

The new guidelines include the recommendation that icosapent ethyl, 2g twice a day, should be considered for patients with cardiovascular disease who have triglyceride levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of cardiovascular events, such as heart attack, stroke or death.

This new recommendation incorporates icosapent ethyl specifically, which was developed by Amarin and marketed under the brand name Vascepa.

“We are pleased by ESC and EAS’s acknowledgement of the significance of the REDUCE-IT results as evidenced by their 2019 updates of the Clinical Practice Guidelines for the Management of Dyslipidaemias,” says Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin.

Granowitz continues, “Amarin believes strongly in the potential for icosapent ethyl to be an important treatment option for the millions of high-risk patients who are on statin therapy with controlled cholesterol levels, yet have elevated triglycerides and other cardiovascular risk factors. This update comes just weeks after the American Heart Association issued an advisory statement referencing REDUCE-IT and the cardiovascular risk-lowering effects of icosapent ethyl and months after the American Diabetes Association included the REDUCE-IT results as part of its updates to the Standards of Medical Care in Diabetes for 2019. All of these updates further support the use of icosapent ethyl as an important treatment option for appropriate patients at high risk of cardiovascular events.”

While the news hasn't helped the stock, despite another analyst upgrade, investors are excited about how the new guidelines can help influence the advisory committee meeting scheduled for November.

The ESC and EAS recommendations are classified as a IIa recommendation denoting that icosapent ethyl should be considered for treatment of such patients. The classification is a Level B recommendation which reflects a relatively high weight of scientific evidence under ESC and EAS standards. Such recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study.

While guidelines from the US are ultimately held with the highest regard to investors and prescribing physicians, the European Society of Cardiology meeting has increasingly become a go-to source for cardiologists around the world.

“These updated guidelines from such prestigious organizations reaffirm the importance of the REDUCE-IT findings to patients globally, not only in enhancing care, but also in broadening awareness of the need for treatment among patients who may have their cholesterol controlled with a statin, but remain at risk because of elevated triglycerides,” says Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and principal investigator and steering committee chair for REDUCE-IT. “Based on what we’re learning from REDUCE-IT and the related guidance from ESC and EAS, I foresee the beginning of a global change in clinical practice in how best to treat patients with multifactorial risks of cardiovascular events beyond cholesterol management.”

In the United States, Vascepa is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for an expansion of the Vascepa U.S. FDA label based on the landmark REDUCE-IT results showing reduction of cardiovascular events in high risk patients.

The company plans to submit an application seeking approval for icosapent ethyl in Europe for reducing cardiovascular events before the end of 2019. A similar application has already been submitted and is under priority review by Health Canada.

The complete 2019 updates to the Clinical Practice Guidelines for the Management of Dyslipidaemias can be accessed online by clicking here.