The independent Data Monitoring Committee recommended that AstraZeneca close the Phase III STRENGTH study for Epanova due to the low probability of improving cardiovascular disease risk among patients with mixed dyslipidemia.
The STRENGTH study compares the safety and efficacy of Epanova to a placebo, both in combination with standard-of-care statins.
The pharmaceutical companies in NYC claim that Epanova should be evaluated for its potential benefit in mixed dyslipidemia, but the results have proven to be disappointing. The companies have still not given up on developing cardiovascular drugs to meet patients’ needs, for which they have an extensive pipeline of drugs.
The leaders of the top life sciences consulting firms are obviously disappointed with the results of the STRENGTH study, but at the same time, they are also proud to have answered this crucial scientific question. Furthermore, they appreciate the opportunity of conducting STRENGTH as an industry-academic collaboration.
All trial data will be presented at a medical meeting soon, after which the trial will be closed in an orderly fashion.
Considerations pertaining to finances
Epanova’s intangible assets, worth $533m, are currently being assessed. In the fourth quarter of 2019, impairments will be treated as non-core items. Core earnings are also forecast to be affected by a writedown of up to $100m relating to inventory during the fourth quarter.
The STRENGTH study
This study tests whether Epanova 4g daily compared to placebo (corn oil) can reduce the risk of major adverse cardiovascular events (MACEs) in patients taking optimal statin therapy with mixed dyslipidemia who are at high risk for cardiovascular disease. Thirteen thousand eight hundred and eighty-six patients were enrolled at 675 sites in 22 countries.
Mixed dyslipidemia (MDL)
MDL patients have elevated triglycerides (moderate hypertriglyceridemia) of 175-499mg/dL and low HDL cholesterol. Growing numbers of patients have elevated triglycerides, which can be exacerbated by other conditions such as obesity or diabetes. At least partially improving the condition and reducing cardiovascular risk can be accomplished through lifestyle changes and potentially treating the underlying cause.
EPA and DHA are the key components of Epanova, a fish oil-derived free fatty acid mixture. It is approved in the U.S. and indicated for the treatment of severe hypertriglyceridemia in adult patients, and this indication is not affected by the results of the STRENGTH trial.
An overview of the CVRM in AstraZeneca
CVRM, together with Renal and Metabolism, makes up one of AstraZeneca’s three therapy areas and is the Company’s most important growth driver. AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by reducing risks and tackling co-morbidities as a result of following the science to understand the underlying links between the heart, kidneys and pancreas. By providing transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide, the Company strives to modify or stop the natural progression of cardiovascular and rheumatological diseases and possibly regenerate organs as well.
Founded in 2005, AstraZeneca is a biopharmaceutical company focused on the development, discovery and commercialization of medicines for oncology, cardiology, renal and metabolic diseases, and respiratory diseases. Millions of patients around the world use AstraZeneca’s innovative medicines. The company operates in more than 100 countries.