Amarin fails to secure backing of FDA panel for expanded use
FDA is scheduled to decide whether to clear the drug for wider use by December 20th
Amarin should complete a cardiovascular study before an approval decision for patients with high triglycerides, a Food and Drug Administration (FDA) advisory panel said, on a vote of 9-2. That study is not expected to deliver results until 2016.
The FDA is scheduled to decide whether to clear the drug for wider use by December 20th. The agency doesn’t have to follow the advisers’ recommendation.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat “very high” triglycerides, a measure of fat in the blood.
Expanded approval would give Amarin access to 36 million potential customers in the US who have elevated triglycerides, or nine times the existing pool of people with severely high triglyceride levels.
The company is seeking to treat high triglyceride patients on statin therapy who have low levels of good cholesterol and coronary heart disease.