Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted: “The…
FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial
October 16, 2013 by Leave a Comment
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%…
Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa
October 14, 2013 by Leave a Comment
On Wednesday an FDA advisory panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions…
FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators
March 22, 2013 by Leave a Comment
Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist…
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