Amarin’s fish oil drug shows 25 percent drop in serious cardiovascular outcomes

By PharmaCompass

2018-09-27

Impressions: 50 Article

Amarin Pharmaceuticals, a biopharma company, made history this week in the field of heart medicines with its proprietary, prescription formulation of fish oil called, known as Vascepa (Ethyl eicosapentaenoic acid). The clinical trial results revealed that Vascepa, which contains omega-3 fatty acids, reduced the risk of deaths, heart attacks, strokes and other serious cardiovascular outcomes quite significantly.

Amarin designed its cardiovascular outcomes study, known as REDUCE-IT, on the hope that Vascepa could meet the primary endpoint with a 15 percent risk reduction. The study involved 8,179 patients. The result, however, showed a significant 25 percent risk reduction.

“This is absolutely the most significant study in the field of cardiovascular risk reduction since the statins were introduced,” Dr. Matthew Budoff, a cardiologist at UCLA and a Vascepa study investigator, said.

The result is likely to transform the fortunes of Amarin.

There are several treatments for heart-related ailments, such as statins and PCSK9 inhibitors. In the case of statins, clinical trials have proven a positive link between lowering of cholesterol and the prevention of fatal heart attacks and strokes.

The newer class of injectable cholesterol-lowering medicines known as PCSK9 inhibitors from Amgen, Regeneron Pharma, and Sanofi reduce cardiovascular risk by 15 percent. With a 25 percent reduction risk for patients, Vascepa could be the next cardiovascular blockbuster therapy.

John F. Thero, Amarin’s president and chief executive, said Vascepa could “lead to a new paradigm in treatment” to further reduce the significant cardiovascular risk. Vascepa was approved by the FDA in 2012 to treat people with high levels of triglycerides, a type of fat found in blood. But the product’s commercial output has been modest — last year, its sales totaled US$ 181 million because there was no scientific proof linking triglyceride lowering to improved cardiovascular outcomes.

In fact, all previous studies investigating different formulations of omega-3-containing products have been unsuccessful. In August this year, a 15,000-patient study of a different prescription-grade fish oil called Lovaza (Omega-3 acid ethyl esters) failed to detect any improvement in heart benefits.

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