Max Nisen, Columnist

This Fish-Oil Heart Drug Will Be Big, Could Be Huge

After a ringing regulatory endorsement, Amarin’s Vascepa looks as if it will become available to more patients. But just how many?

A relatively low-cost drug could have a big impact on heart health.

Photographer: Bloomberg

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Drugmaker Amarin Corp Plc shocked the world last year when a long-running clinical trial showed that its medicine derived from purified fish oil, Vascepa, substantially reduced the risk of cardiovascular events like heart attacks in high-risk patients. After the euphoria and 300% stock rally off the news faded, the question remained precisely how big a blockbuster it might be.

Part of that question was answered Thursday after a panel of experts convened by the Food and Drug Administration reviewed Amarin's data. They voted 16 to 0 that Vascepa was safe and cuts cardiovascular events. The vote doesn’t bind the FDA, but the agency often follows panel recommendations, so it would be a surprise now if the drug isn’t made available to more Americans. That’s big news for Amarin — and for many patients.