Purified fish oil can reduce patients’ risks for adverse cardiovascular events by 25%, according to US-Irish Biotech Amarin’s Phase III trial results.
The treatment, called Vascepa, significantly reduced the risk of strokes, heart attacks, and death. It also had a good safety profile in the over 8,000 enrolled patients, who were already taking statins. These patients had either already had an adverse event, or had diabetes and a high risk of experiencing one.
In response to the positive news, Amarin’s stock prices tripled, and have stayed high this week.
Cardiovascular diseases are the biggest cause of death globally, accounting for 31% of mortality. If the benefits of Vascepa hold out, this could provide big profits for Amarin, as well as benefits for a huge segment of the population.
The results are welcome after a recent large trial of another fish oil-derivative failed to find evidence that it reduced the risk of cardiovascular events in patients with diabetes. Amarin brushed aside concerns resulting from that trial, insisting that its different formulation and dosage would yield results.
The company’s product is not the same as over-the-counter fish oil supplements, which contain a mixture of different omega-3 acids. Vascepa is a purified form of one omega-3 acid, EPA, and was approved by the FDA to lower triglycerides in patients in 2013. As it now has evidence that Vascepa lowers the risk of cardiovascular events, Amarin will apply for FDA approval to market the product with this new claim.
Amarin is yet to publish the entire set of clinical data but will present it later this year. It remains to be seen if the full results back up the initial promising findings. AstraZeneca is also testing a fish oil-derivative compound in a clinical trial in patients with cardiovascular disease, which is due to finish later next year. Time will tell if both companies can enjoy an unexpected bumper catch.
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