The FDA has authorized a new omega-three supplement for the remedy of grownups with serious hypertriglyceridemia, defined as triglyceride amounts 500 mg/dL or higher. The drug, which will be marketed under the brand identify of Epanova, is produced by AstraZeneca, which acquired the drug when it obtained Omthera Pharmaceuticals in 2013.
AstraZeneca mentioned that Epanova is the very first omega-three formulation approved by the FDA in free fatty acid form. Epanova will be accessible in 1 gram capsules and has been authorized for 2 gram and four gram dosages, which can be taken with or with out food.
There are at the moment two other prescription formulations of omega-3 dietary supplements: Lovaza from GSK and Vascepa from Amarin Pharmaceuticals. All 3 are accepted only for the remedy of serious hypertriglyceridemia. Last yr the FDA turned down a request from Amarin to enable an expanded use of Vascepa in people with a lot more frequent forms of dyslipidemia. The expanded indication for Vascepa is now becoming studied in the ongoing REDUCE-IT trial, which is scheduled to enroll 8,000 individuals.
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.
FDA Approves New Omega-3 Supplement
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