FDA Approves New Omega-3 Supplement

May 6th, 2014

FDA Approves New Omega-3 Supplement

Larry Husten, PHD

The FDA has approved a new omega-3 supplement for the treatment of adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher. The drug, which will be marketed under the brand name of Epanova, is manufactured by AstraZeneca, which acquired the drug when it purchased Omthera Pharmaceuticals in 2013.

AstraZeneca said that Epanova is the first omega-3 formulation approved by the FDA in free fatty acid form. Epanova will be available in 1-g capsules and has been approved for 2-g and 4-g dosages, which can be taken with or without food.

There are currently two other prescription formulations of omega-3 supplements: Lovaza from GSK and Vascepa from Amarin Pharmaceuticals. All three are approved only for the treatment of severe hypertriglyceridemia. Last year the FDA turned down a request from Amarin to allow an expanded use of Vascepa in people with more common forms of dyslipidemia. The expanded indication for Vascepa is now being studied in the ongoing REDUCE-IT trial, which is scheduled to enroll 8000 patients.

The use of Epanova in an expanded population will be studied in the 12,000-patient STRENGTH study, headed by the Cleveland Clinic’s Steve Nissen, Michael Lincoff, and Stephen Nicholls.

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May 6th, 2014