Breaking News!The FDA is scheduled to decide whether to clear the drug for wider use by Dec. 20. The agency doesn’t have to follow the panel’s advice
Amarin should complete a study on the drug’s ability to benefit the heart before an approval decision for patients with high triglycerides, a Food and Drug Administration advisory panel voted 9-2 today in Silver Spring, Maryland. The FDA is scheduled to decide whether to clear the drug for wider use by Dec. 20. The agency doesn’t have to follow the panel’s advice.
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 Dublin-based Amarin access to 36 million potential U.S. customers who have elevated triglycerides, or nine times the pool of people with severely high levels. The company is seeking to treat high triglyceride patients on statin therapy who have low levels of good cholesterol and coronary heart disease.
“Let’s see the results in an outcomes trial,” Peter Wilson, a panel member and professor at Emory University’s School of Medicine in Atlanta, said during the meeting. “That’s really where the proof is, in the pudding, in my view.”