FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial

An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of the US population who have elevated triglycerides (>200 mg/dl) and existing CV disease or who are at high risk for CV disease.

Click here to read the full story on Forbes.

 

 

 

 

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