AZ were disappointed that it has had to terminate the Phase III STRENGTH study of Epanova in MDL patients at heightened risk of CV disease. Credit: Shutterstock.

AstraZeneca (AZ) has announced the termination of its Phase III STRENGTH trial of Epanova (omega-3 carboxylic acids) following a recommendation by an Independent Data Monitory Committee that the drug was unlikely to demonstrate cardiovascular (CV) benefit to the target patient group.

As a result of this decision, AZ noted there would be a write down of up to $100m due to the inventories on this $553m intangible asset, which was expected to impact fourth quarter 2019 earnings. There will also be a review of the ongoing value of asset itself.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The STRENGTH study was investigating the safety and efficacy of Epanova in patients with mixed dyslipidaemia (MDL) and at increased risk of CV disease, compared to placebo. Both study groups were also given standard-of-care statins and a total of 13,086 patients had been enrolled globally.

AZ research and development executive vice-president Mene Pangalos said: “It was important to assess the potential benefit of Epanova in mixed dyslipidaemia.

“We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline.”

STRENGTH study chair and Cleveland Clinic Heart and Vascular Institute chief academic officer Steven E. Nissen MD echoed this sentiment, saying: “The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

MDL is characterised as patients with high triglyceride levels, known as moderate hypertriglyceridemia, and low HDL cholesterol.

Epanova is a fish oil-derived combination of three fatty acids, which significantly bolsters the levels of eicosapentaenoic acid and docosahexaenoic acid in the blood.

AZ acquired the asset when it bought New Jersey-based Omthera Pharmaceuticals in 2013 for approximately $323m. One year later Epanova received approval in the US for adults with severe hypertriglyceridemia – AZ emphasised that the termination of the STRENGTH trial would not affect treatment of this patient group.