Omega-3 Drug Granted NCE Marketing Exclusivity


FDA has determined Amarin’s Vascepa EPA omega-3 drug is eligible for new chemical entity (NCE) marketing exclusivity. Will it impact omega-3 supplements?

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Vascepa, an EPA omega-3 drug for hypertriglyceridemia from pharmaceutical firm Amarin (Dublin), has been granted marketing exclusivity as a new chemical entity (NCE) from FDA. The five-year NCE exclusivity runs through 2017 (five years after Vascepa’s FDA approval in 2012), although Amarin says it has multiple patents protecting the commercial potential of Vascepa through 2030.

The Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City) shared the Vascepa news earlier this week, which arrives during a time when the “pharmaceutical omega-3 segment is extremely active overall, with more than 70 omega-3 pharma targets in the drug discovery pipeline.”

While GOED does not anticipate Vascepa’s NCE status will impact the omega-3 dietary supplement industry either now or when the exclusivity expires, there are still plenty of reasons to keep an eye on the omega-3 drug sector, and many of them are positive.

“In general, the omega-3 supplement category benefits when pharmaceutical omega-3s are introduced because this increases the credibility and trust in the category,” Ellen Schutt, communications director for GOED, tells Nutritional Outlook.

However, she adds that there are still instances when omega-3 drugs can harm the omega-3 supplements industry.

“One, if new research comes out that is negative about the benefits of omega-3s, it could damage the market,” says Schutt. “And two, if pharmaceutical companies actively promote a ‘pharmaceuticals only’ approach-which is already happening-this does not help the entire category.”

The full announcement of Vascepa’s NCE status can be found here.


Read more:

FDA Approves Three More Omega-3 Drugs. Is This Good or Bad News for Supplements?

New Breakthroughs in Omega-3 Research

Widespread Omega-3 Usage Could Save €12.9 Billion in Annual EU Healthcare Costs, Study Suggests


Michael Crane
Associate Editor
Nutritional Outlook Magazine

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