Following the recommendation from an independent Data Monitoring Committee, AstraZeneca has decided to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular (CV) disease.
STRENGTH is a large-scale, global CV outcomes trial designed to evaluate the safety and efficacy of Epanova compared to placebo, both in combination with standard-of-care statin medicines.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.'
Steven E. Nissen MD, Study Chair for the STRENGTH trial and Chief Academic Officer for the Heart and Vascular Institute, Cleveland Clinic, US, said: '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. We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry.'
This trial will now be closed in an orderly fashion, and full data will be presented at a forthcoming medical meeting.
A review is being undertaken of the ongoing value of the $533m Epanova intangible asset. Any impairment will be treated as a non-Core item in the fourth quarter of 2019. A write down of up to $100m relating to inventories is also anticipated to impact the Core earnings in the fourth quarter of 2019.