AstraZeneca PLC has dropped a late-stage study of heart disease medicine Epanova in people with unusually high levels of fat in their blood, after an independent committee said it was unlikely to be effective in those with an increased risk of heart disease.
The phase 3 Strength study of 13,086 patients on statin drugs at high risk of heart disease was designed to see if Epanova was safe and effective at cutting the number of cardiovascular events compared with placebo. The study of Epanova, a fish oil derived medicine approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia, is now being closed.
"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," said Steven Nissen, chair for the Strength trial and chief academic officer for the Heart and Vascular Institute at the Cleveland Clinic.
Astrazeneca is now reviewing the $533 million value of Epanova and will write down up to $100 million worth of inventories in the fourth quarter of 2019.