Amarin’s Triglyceride-Lowering Drug Gets Second FDA Nod to Tackle Cardiovascular Disease

16/12/2019 - 2 minutes

A treatment developed by the Irish company Amarin has become the first FDA-approved drug to lower the risk of strokes and heart attacks when combined with statins in patients with high levels of circulating fat molecules called triglycerides. 

To be eligible for Vascepa, patients must also either have established cardiovascular disease, or type 2 diabetes and two or more risk factors for cardiovascular disease. 

Vascepa works by lowering triglycerides in the blood, high levels of which are linked to cardiovascular disease. Vascepa was first approved by the FDA in 2012 for treating patients with very high triglyceride levels.  The latest approval has opened up the use of Vascepa to patients with less severely elevated triglycerides, expanding its reach to many more patients.

The latest approval comes after a phase III trial in 8,000 patients in which Vascepa cut the risk of cardiovascular events by an impressive 25% compared to a placebo. In combination with statins, which lower levels of harmful cholesterol in the blood, Vascepa could reduce deaths from cardiovascular disease, the biggest killer worldwide.

Fish oil tablets are commonly sold as dietary supplements. They mainly consist of a mix of two omega-3 fatty acids called EPA and DHA. Vascepa, on the other hand, is a purified form of EPA without containing DHA.

Vascepa will face competition going forward as AstraZeneca has its own fish oil product, Epanova, which consists of a mix of EPA and DHA. The drug is currently in a phase III trial to see if it can reduce the rate of heart attacks and cardiovascular death, with results expected in August 2020.

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Developing new treatments for cardiovascular disease beyond statins has proven difficult. One reason is that the condition is so common that clinical trials need to be a lot bigger than for other conditions, making it less affordable for biotech companies. There is also the risk of the trial failing, as happened with the Belgian company Celyad and the French biotech Cerenis in recent years. Technology is advancing, however, and one day we could see gene editing therapies, bioprinted hearts or even artificial hearts.

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