Different lives of the same kind! Phase III clinical failure of the key cardiovascular prognosis of AstraZeneca fish oil products

Compile newborn In December 2019, vascepa, amarin's "fish oil", was approved by the US FDA as the first fish oil derivative drug to reduce the risk of heart disease in patients with hyperlipidemia AstraZeneca is eager to prove that its "fish oil" product, epanova (ω - 3 carboxylic acid), can do the same Now, however, that hope is dashed On January 13, AstraZeneca said it would discontinue the evaluation of epanova as an additional therapy for statins in a large-scale phase III strength study to reduce cardiovascular risk in patients with mixed dyslipidemia (MDL) The decision was based on the recommendation of the independent data monitoring board, which considered the study to be very unlikely to succeed For AstraZeneca, the decision is a direct financial blow Currently, the company is considering a $100 million impairment of the project and reassessment of epanova's current asset value of $533 million Epanova was acquired by AstraZeneca in July 2013 for us $443 million In May 2014, epanova was approved by FDA of the United States It was used in adult patients with severe hypertriglyceridemia (triglyceride level ≥ 500mg / dl) to reduce triglyceride level Soon after that, AstraZeneca launched the phase III strength study, hoping to demonstrate the cardiac benefits of epanova compared with placebo in patients with high triglyceride levels (175-499mg / dl) and low HDL-C Now, after testing 13086 patients for more than five years, we have to face this failure Epanova has not yet been put on the market, as all the bets are on the strength study to reach a wider patient population If the research is successful, epanova has a chance to earn a huge amount of revenue After all, vascepa's cardiovascular risk reduction label leads to heavy sales expectations Michael Yee, an analyst at Jefferies, an investment bank, pointed out in a memo from his clients that the consensus on Wall Street had previously rated the top sales of epanova at $1-2 billion Compared with over-the-counter fish oil food supplements, prescription omega-3 fatty acids (vascepa, epanova and lovaza of GSK) have been approved by the US FDA to reduce triglyceride levels But it wasn't until vascepa expanded its label in December 2019 that the first truly approved drug in the fish oil category was born to reduce the risk of cardiovascular disease.