AstraZeneca announced Tuesday that the FDA approved Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia. The company noted that the product "is the first FDA approved prescription omega-3 in free fatty acid form" and is the first such therapy "to have a dosing option as few as two capsules once a day, with or without food."
The marketing application, which was accepted by the FDA in September last year, included positive data from the Phase III EVOLVE trial investigating the efficacy of Epanova in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. Briggs Morrison, chief medical officer at AstraZeneca, said "this approval is a significant milestone...as it strengthens our existing portfolio of cardiovascular medicines."
"We are committed to further assessing the clinical profile of Epanova and to identifying other patient groups it may benefit," Morrison added. AstraZeneca noted that it is conducting a cardiovascular outcomes trial called STRENGTH, investigating the safety and efficacy of Epanova in combination with statin therapy in patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease. The drugmaker indicated that it will also pursue the development of a fixed-dose combination of Epanova with a statin and plans to seek regulatory approval in other markets for the severe hypertriglyceridaemia indication.
Analysts expect Epanova, which AstraZeneca gained via last year's acquisition of Omthera Pharmaceuticals, to generate annual sales of $322 million by 2018. Similar products already on the market include GlaxoSmithKline's Lovaza, as well as Teva's recently approved generic version in the US, and Amarin's Vascepa.
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