Data from Pharmawand - Curated by EPG Health - Date added 10 August 2019

The FDA has announced plans to hold an advisory panel review of Vascepa (icosapent ethyl) from Amarin, tentatively scheduled for November 14. Due to this surprise decision, the FDA is now not expected to rule on an expanded approval for Vascepa until December 2019, three months later than the late September PDUFA date anticipated under a priority review.

Amarin hopes to broaden the indication for Vascepa to include claims that the drug offers a benefit to heart health in a wider population. Results from a trial of more than 8,000 patients, called REDUCE-IT, first announced in autumn 2018, showed Vascepa could cut heart risk by a quarter versus placebo.

Comment: the REDUCE-IT study showed that Vascepa provided a statistically significant 30% risk reduction in total (first and subsequent) cardiovascular events compared to placebo in the statin-treated patient population studied in REDUCE-IT. These data were presented at the American College of Cardiology's (ACC) 68th Annual Scientific Session and published simultaneously in the Journal of the American College of Cardiology.


You will need to login, to leave a comment. is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Load more

Related Content